FDA — authorised 7 November 1968
- Application: NDA016401
- Marketing authorisation holder: POLYMEDICA
- Local brand name: NEOPAP
- Indication: SUPPOSITORY — RECTAL
- Status: approved
🇺🇸 Acetaminophen in United States
FDA authorised Acetaminophen on 7 November 1968
Marketing authorisations
FDA — authorised 18 October 1972
- Application: NDA016844
- Marketing authorisation holder: AAIPHARMA LLC
- Local brand name: DARVOCET
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 May 1974
- Application: ANDA083643
- Marketing authorisation holder: CARNRICK
- Local brand name: CAPITAL AND CODEINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 October 1974
- Application: ANDA083978
- Marketing authorisation holder: MYLAN
- Local brand name: PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 October 1974
- Application: ANDA083689
- Marketing authorisation holder: MYLAN
- Local brand name: PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 May 1976
- Application: ANDA084656
- Marketing authorisation holder: ROXANE
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 May 1976
- Application: ANDA084659
- Marketing authorisation holder: ROXANE
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 May 1976
- Application: ANDA084667
- Marketing authorisation holder: ROXANE
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 September 1976
- Application: ANDA084999
- Marketing authorisation holder: CARACO
- Local brand name: WYGESIC
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 February 1977
- Application: ANDA085291
- Marketing authorisation holder: SANDOZ
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 August 1977
- Application: ANDA085055
- Marketing authorisation holder: JANSSEN PHARMS
- Local brand name: TYLENOL W/ CODEINE NO. 2
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 August 1977
- Application: ANDA085363
- Marketing authorisation holder: KV PHARM
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 August 1977
- Application: ANDA085288
- Marketing authorisation holder: KV PHARM
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 August 1977
- Application: ANDA085365
- Marketing authorisation holder: KV PHARM
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 August 1977
- Application: ANDA085364
- Marketing authorisation holder: KV PHARM
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 December 1977
- Application: ANDA084360
- Marketing authorisation holder: WHITEWORTH TOWN PLSN
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 January 1978
- Application: ANDA085794
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 January 1978
- Application: ANDA085795
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 February 1978
- Application: NDA018060
- Marketing authorisation holder: COSETTE
- Local brand name: ACEPHEN
- Indication: SUPPOSITORY — RECTAL
- Status: approved
FDA — authorised 14 March 1978
- Application: ANDA085218
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 March 1978
- Application: ANDA085992
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 March 1978
- Application: ANDA085217
- Marketing authorisation holder: EVERYLIFE
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 April 1978
- Application: ANDA085896
- Marketing authorisation holder: VALEANT PHARM INTL
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 July 1978
- Application: ANDA085607
- Marketing authorisation holder: WHITEWORTH TOWN PLSN
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 July 1978
- Application: ANDA085964
- Marketing authorisation holder: SANDOZ
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 January 1979
- Application: ANDA085883
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: CAPITAL AND CODEINE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 8 January 1979
- Application: ANDA086024
- Marketing authorisation holder: VALEANT PHARMS LLC
- Local brand name: CAPITAL AND CODEINE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 27 March 1979
- Application: ANDA086366
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 11 May 1979
- Application: ANDA086681
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 May 1979
- Application: ANDA086683
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 January 1980
- Application: ANDA087083
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 April 1980
- Application: NDA018337
- Marketing authorisation holder: TARO
- Local brand name: ACETAMINOPHEN
- Indication: SUPPOSITORY — RECTAL
- Status: approved
FDA — authorised 12 August 1980
- Application: ANDA085917
- Marketing authorisation holder: SANDOZ
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 February 1981
- Application: ANDA087306
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 July 1981
- Application: ANDA087423
- Marketing authorisation holder: SANDOZ
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 August 1981
- Application: ANDA087508
- Marketing authorisation holder: GENUS LIFESCIENCES
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 29 September 1981
- Application: ANDA087422
- Marketing authorisation holder: ORTHO MCNEIL PHARM
- Local brand name: TYLENOL W/ CODEINE NO. 3
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 September 1981
- Application: ANDA087421
- Marketing authorisation holder: ORTHO MCNEIL PHARM
- Local brand name: TYLENOL W/ CODEINE NO. 4
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 13 April 1982
- Application: ANDA087653
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 May 1982
- Application: ANDA087757
- Marketing authorisation holder: UCB INC
- Local brand name: CO-GESIC
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 May 1982
- Application: ANDA087677
- Marketing authorisation holder: ASCHER
- Local brand name: HY-PHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 May 1982
- Application: ANDA087275
- Marketing authorisation holder: WATSON LABS
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 May 1982
- Application: ANDA087277
- Marketing authorisation holder: WATSON LABS
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 May 1982
- Application: ANDA087276
- Marketing authorisation holder: WATSON LABS
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 June 1982
- Application: ANDA087919
- Marketing authorisation holder: USL PHARMA
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 June 1982
- Application: ANDA087920
- Marketing authorisation holder: USL PHARMA
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 July 1982
- Application: ANDA087336
- Marketing authorisation holder: MALLINCKRODT
- Local brand name: LORCET-HD
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 23 September 1982
- Application: NDA018458
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: TALACEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 November 1982
- Application: ANDA087141
- Marketing authorisation holder: LEDERLE
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 December 1982
- Application: ANDA087762
- Marketing authorisation holder: PURACAP PHARM
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 March 1983
- Application: ANDA087961
- Marketing authorisation holder: FOREST PHARMS
- Local brand name: BANCAP HC
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 December 1983
- Application: ANDA088324
- Marketing authorisation holder: TEVA
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 6 February 1984
- Application: ANDA088353
- Marketing authorisation holder: DURAMED PHARMS BARR
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 February 1984
- Application: ANDA088354
- Marketing authorisation holder: DURAMED PHARMS BARR
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 February 1984
- Application: ANDA088355
- Marketing authorisation holder: DURAMED PHARMS BARR
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 March 1984
- Application: ANDA088037
- Marketing authorisation holder: VANGARD
- Local brand name: PAPA-DEINE #3
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 March 1984
- Application: ANDA088715
- Marketing authorisation holder: VANGARD
- Local brand name: PAPA-DEINE #4
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 June 1984
- Application: ANDA088599
- Marketing authorisation holder: TEVA
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 4 June 1984
- Application: ANDA088537
- Marketing authorisation holder: TEVA
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 October 1984
- Application: ANDA087550
- Marketing authorisation holder: WATSON LABS
- Local brand name: BUTALBITAL AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 November 1984
- Application: ANDA088246
- Marketing authorisation holder: ORTHO MCNEIL PHARM
- Local brand name: TYLOX-325
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 6 March 1985
- Application: ANDA088629
- Marketing authorisation holder: ANI PHARMS
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 March 1985
- Application: ANDA088898
- Marketing authorisation holder: CENT PHARMS
- Local brand name: ACETAMINOPHEN AND HYDROCODONE BITARTRATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 12 June 1985
- Application: ANDA070115
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 June 1985
- Application: ANDA088831
- Marketing authorisation holder: VALEANT
- Local brand name: PHRENILIN FORTE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 June 1985
- Application: ANDA088991
- Marketing authorisation holder: MALLINCKRODT
- Local brand name: BUCET
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 August 1985
- Application: ANDA070146
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 October 1985
- Application: ANDA070116
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 October 1985
- Application: ANDA088944
- Marketing authorisation holder: MAYRAND
- Local brand name: SEDAPAP
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 December 1985
- Application: ANDA070145
- Marketing authorisation holder: MYLAN PHARMS INC
- Local brand name: PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 February 1986
- Application: ANDA089238
- Marketing authorisation holder: MIKART
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 February 1986
- Application: ANDA089244
- Marketing authorisation holder: MIKART
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 March 1986
- Application: ANDA089231
- Marketing authorisation holder: MIKART
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 March 1986
- Application: ANDA088584
- Marketing authorisation holder: PHARM RES ASSOC
- Local brand name: DHC PLUS
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 21 March 1986
- Application: ANDA070771
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 March 1986
- Application: ANDA070615
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 March 1986
- Application: ANDA070775
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 May 1986
- Application: ANDA088871
- Marketing authorisation holder: ABANA
- Local brand name: NORCET
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 May 1986
- Application: ANDA089253
- Marketing authorisation holder: SUPERPHARM
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 May 1986
- Application: ANDA089254
- Marketing authorisation holder: SUPERPHARM
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 July 1986
- Application: ANDA089080
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 August 1986
- Application: ANDA089385
- Marketing authorisation holder: ORTHO MCNEIL PHARM
- Local brand name: TYCOLET
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 September 1986
- Application: ANDA070443
- Marketing authorisation holder: SANDOZ
- Local brand name: PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 October 1986
- Application: ANDA087628
- Marketing authorisation holder: SHIRE
- Local brand name: ANOQUAN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 1 December 1986
- Application: ANDA070608
- Marketing authorisation holder: PERRIGO NEW YORK
- Local brand name: ACETAMINOPHEN
- Indication: SUPPOSITORY — RECTAL
- Status: approved
FDA — authorised 3 December 1986
- Application: ANDA089351
- Marketing authorisation holder: HIKMA
- Local brand name: ROXICET
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 6 January 1987
- Application: ANDA071319
- Marketing authorisation holder: SUPERPHARM
- Local brand name: PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 March 1987
- Application: ANDA089479
- Marketing authorisation holder: AM THERAP
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 March 1987
- Application: ANDA089478
- Marketing authorisation holder: AM THERAP
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 March 1987
- Application: ANDA089483
- Marketing authorisation holder: AM THERAP
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 March 1987
- Application: ANDA089482
- Marketing authorisation holder: AM THERAP
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 March 1987
- Application: ANDA089481
- Marketing authorisation holder: AM THERAP
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 March 1987
- Application: ANDA089480
- Marketing authorisation holder: AM THERAP
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 May 1987
- Application: ANDA071011
- Marketing authorisation holder: ACINO PRODS
- Local brand name: ACETAMINOPHEN
- Indication: SUPPOSITORY — RECTAL
- Status: approved
FDA — authorised 12 May 1987
- Application: ANDA071010
- Marketing authorisation holder: ACINO PRODS
- Local brand name: ACETAMINOPHEN
- Indication: SUPPOSITORY — RECTAL
- Status: approved
FDA — authorised 22 May 1987
- Application: NDA019453
- Marketing authorisation holder: SCHERING PLOUGH
- Local brand name: DRIXORAL PLUS
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 2 July 1987
- Application: ANDA089268
- Marketing authorisation holder: DUNHALL
- Local brand name: TRIAPRIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 September 1987
- Application: ANDA089725
- Marketing authorisation holder: MALLINCKRODT
- Local brand name: ANEXSIA 7.5/650
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 February 1988
- Application: ANDA089673
- Marketing authorisation holder: RHODES PHARMS
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 February 1988
- Application: ANDA072195
- Marketing authorisation holder: MYLAN
- Local brand name: PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 May 1988
- Application: ANDA072105
- Marketing authorisation holder: HALSEY
- Local brand name: PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 May 1988
- Application: ANDA089451
- Marketing authorisation holder: MIKART
- Local brand name: ESGIC-PLUS
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 September 1988
- Application: ANDA089805
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 September 1988
- Application: ANDA089828
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 September 1988
- Application: ANDA089990
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 December 1988
- Application: ANDA089736
- Marketing authorisation holder: ABBVIE
- Local brand name: VICODIN ES
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 January 1989
- Application: ANDA089775
- Marketing authorisation holder: ROXANE
- Local brand name: ROXICET 5/500
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 January 1989
- Application: ANDA089907
- Marketing authorisation holder: IVAX PHARMS
- Local brand name: ALLAY
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 July 1989
- Application: ANDA089959
- Marketing authorisation holder: SANDOZ
- Local brand name: PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 May 1990
- Application: ANDA089405
- Marketing authorisation holder: MALLINCKRODT
- Local brand name: TENCON
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 26 October 1990
- Application: ANDA081097
- Marketing authorisation holder: MIKART
- Local brand name: ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 26 October 1990
- Application: ANDA081096
- Marketing authorisation holder: MIKART
- Local brand name: ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 26 October 1990
- Application: ANDA081095
- Marketing authorisation holder: MIKART
- Local brand name: ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 25 September 1991
- Application: ANDA089363
- Marketing authorisation holder: MIKART
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 March 1992
- Application: ANDA072344
- Marketing authorisation holder: COSETTE
- Local brand name: ACEPHEN
- Indication: SUPPOSITORY — RECTAL
- Status: approved
FDA — authorised 27 March 1992
- Application: ANDA072218
- Marketing authorisation holder: COSETTE
- Local brand name: ACEPHEN
- Indication: SUPPOSITORY — RECTAL
- Status: approved
FDA — authorised 27 March 1992
- Application: ANDA072237
- Marketing authorisation holder: COSETTE
- Local brand name: ACEPHEN
- Indication: SUPPOSITORY — RECTAL
- Status: approved
FDA — authorised 16 July 1992
- Application: ANDA081249
- Marketing authorisation holder: FOSUN PHARMA
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 July 1992
- Application: ANDA081250
- Marketing authorisation holder: FOSUN PHARMA
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 October 1992
- Application: ANDA089988
- Marketing authorisation holder: MIKART
- Local brand name: BUTAPAP
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 October 1992
- Application: ANDA089987
- Marketing authorisation holder: MIKART
- Local brand name: BUTAPAP
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 October 1992
- Application: ANDA089450
- Marketing authorisation holder: CHARTWELL
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 28 December 1994
- Application: ANDA089997
- Marketing authorisation holder: CHARTWELL
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 December 1994
- Application: ANDA089999
- Marketing authorisation holder: CHARTWELL
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 December 1994
- Application: ANDA089998
- Marketing authorisation holder: CHARTWELL
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 July 1995
- Application: ANDA040061
- Marketing authorisation holder: ROXANE
- Local brand name: ROXILOX
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 March 1996
- Application: ANDA040085
- Marketing authorisation holder: MIKART
- Local brand name: ESGIC-PLUS
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 26 April 1996
- Application: ANDA040119
- Marketing authorisation holder: PAI HOLDINGS
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 20 September 1996
- Application: ANDA040098
- Marketing authorisation holder: DAVA PHARMS INC
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 23 September 1996
- Application: ANDA040117
- Marketing authorisation holder: ABBVIE
- Local brand name: VICODIN HP
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 December 1996
- Application: ANDA040139
- Marketing authorisation holder: WATSON LABS
- Local brand name: PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 February 1997
- Application: ANDA074843
- Marketing authorisation holder: VINTAGE PHARMS
- Local brand name: PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 August 1997
- Application: ANDA040109
- Marketing authorisation holder: MIKART
- Local brand name: ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 November 1997
- Application: ANDA040223
- Marketing authorisation holder: DURAMED PHARMS BARR
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 November 1998
- Application: ANDA040288
- Marketing authorisation holder: VINTAGE PHARMS LLC
- Local brand name: ZYDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 April 1999
- Application: ANDA040316
- Marketing authorisation holder: MIKART
- Local brand name: ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 February 2000
- Application: ANDA075077
- Marketing authorisation holder: PERRIGO
- Local brand name: ACETAMINOPHEN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 24 March 2000
- Application: ANDA074699
- Marketing authorisation holder: WATSON LABS
- Local brand name: ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 September 2000
- Application: ANDA040405
- Marketing authorisation holder: SPECGX LLC
- Local brand name: ANEXSIA 7.5/325
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 October 2000
- Application: ANDA040409
- Marketing authorisation holder: SPECGX LLC
- Local brand name: ANEXSIA 5/325
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 February 2001
- Application: ANDA075738
- Marketing authorisation holder: MALLINCKRODT
- Local brand name: PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 March 2001
- Application: NDA021082
- Marketing authorisation holder: NOVARTIS
- Local brand name: TAVIST ALLERGY/SINUS/HEADACHE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 May 2001
- Application: ANDA040419
- Marketing authorisation holder: SPECGX LLC
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 July 2001
- Application: ANDA075838
- Marketing authorisation holder: ABLE
- Local brand name: PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 August 2001
- Application: ANDA074911
- Marketing authorisation holder: VALEANT
- Local brand name: PHRENILIN WITH CAFFEINE AND CODEINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 26 November 2001
- Application: ANDA075794
- Marketing authorisation holder: PERRIGO
- Local brand name: ACETAMINOPHEN, ASPIRIN AND CAFFEINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 March 2002
- Application: ANDA076200
- Marketing authorisation holder: OHM LABS
- Local brand name: ACETAMINOPHEN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 1 August 2002
- Application: ANDA040452
- Marketing authorisation holder: ABLE
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 August 2002
- Application: ANDA076202
- Marketing authorisation holder: GAVIS PHARMS
- Local brand name: ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 January 2003
- Application: ANDA040443
- Marketing authorisation holder: WATSON LABS FLORIDA
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 February 2003
- Application: ANDA040447
- Marketing authorisation holder: WATSON LABS FLORIDA
- Local brand name: CODRIX
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 March 2003
- Application: ANDA040441
- Marketing authorisation holder: WATSON LABS FLORIDA
- Local brand name: CODRIX
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 July 2003
- Application: ANDA040507
- Marketing authorisation holder: VINTAGE PHARMS
- Local brand name: PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 May 2004
- Application: ANDA076743
- Marketing authorisation holder: CORNERSTONE
- Local brand name: PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 June 2004
- Application: ANDA076750
- Marketing authorisation holder: CORNERSTONE
- Local brand name: PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 November 2004
- Application: ANDA076609
- Marketing authorisation holder: WATSON LABS FLORIDA
- Local brand name: PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 April 2005
- Application: ANDA076475
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 June 2005
- Application: ANDA077196
- Marketing authorisation holder: WATSON LABS FLORIDA
- Local brand name: PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 December 2005
- Application: ANDA077184
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 July 2006
- Application: ANDA076914
- Marketing authorisation holder: GRAVITI PHARMS
- Local brand name: TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 September 2006
- Application: ANDA040637
- Marketing authorisation holder: WEST-WARD PHARM CORP
- Local brand name: ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 March 2007
- Application: ANDA077677
- Marketing authorisation holder: WOCKHARDT LTD
- Local brand name: PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 April 2007
- Application: ANDA040701
- Marketing authorisation holder: BOCA PHARMA LLC
- Local brand name: ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 April 2007
- Application: ANDA040688
- Marketing authorisation holder: WRASER PHARMS LLC
- Local brand name: ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 11 February 2008
- Application: ANDA077821
- Marketing authorisation holder: MIRROR PHARMS
- Local brand name: PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 September 2008
- Application: ANDA077858
- Marketing authorisation holder: RISING
- Local brand name: TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 November 2009
- Application: ANDA090205
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: ACETAMINOPHEN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 9 December 2009
- Application: ANDA090485
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 August 2011
- Application: ANDA090956
- Marketing authorisation holder: LGM PHARMA
- Local brand name: BUTALBITAL AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 November 2011
- Application: ANDA091238
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 14 December 2011
- Application: ANDA078569
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: ACETAMINOPHEN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 6 September 2012
- Application: ANDA090460
- Marketing authorisation holder: ZYDUS PHARMS USA INC
- Local brand name: TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 December 2012
- Application: ANDA201952
- Marketing authorisation holder: MICRO LABS LTD INDIA
- Local brand name: TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 April 2013
- Application: ANDA202800
- Marketing authorisation holder: AUROLIFE PHARMA LLC
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 March 2014
- Application: NDA204031
- Marketing authorisation holder: MALLINCKRODT INC
- Local brand name: XARTEMIS XR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 26 November 2014
- Application: ANDA204785
- Marketing authorisation holder: KEY THERAP
- Local brand name: TREZIX
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 December 2014
- Application: ANDA203573
- Marketing authorisation holder: PH HEALTH
- Local brand name: OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 28 October 2015
- Application: NDA204767
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: ACETAMINOPHEN
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 30 October 2015
- Application: ANDA205120
- Marketing authorisation holder: ALVOGEN
- Local brand name: BUTALBITAL AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 December 2015
- Application: ANDA203484
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: BUTALBITAL AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 March 2016
- Application: ANDA204052
- Marketing authorisation holder: SANDOZ
- Local brand name: ACETAMINOPHEN
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 14 April 2016
- Application: ANDA090468
- Marketing authorisation holder: CYPRESS PHARM INC
- Local brand name: ZYFREL
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 13 June 2016
- Application: ANDA202605
- Marketing authorisation holder: HIKMA
- Local brand name: ACETAMINOPHEN
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 30 September 2016
- Application: ANDA204209
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 November 2016
- Application: ANDA207229
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: ACETAMINOPHEN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 22 March 2017
- Application: ANDA207152
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 May 2017
- Application: ANDA206885
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 June 2017
- Application: ANDA207635
- Marketing authorisation holder: ALVOGEN
- Local brand name: BUTALBITAL AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 December 2017
- Application: ANDA207313
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: BUTALBITAL AND ACETAMINOPHEN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 23 February 2018
- Application: NDA208653
- Marketing authorisation holder: ZEVRA THERAP
- Local brand name: APADAZ
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 April 2019
- Application: ANDA211544
- Marketing authorisation holder: GRANULES
- Local brand name: ACETAMINOPHEN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 10 September 2019
- Application: ANDA212418
- Marketing authorisation holder: ELITE LABS INC
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 November 2019
- Application: ANDA213115
- Marketing authorisation holder: GRANULES
- Local brand name: BUTALBITAL AND ACETAMINOPHEN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 February 2020
- Application: NDA211733
- Marketing authorisation holder: HALEON US HOLDINGS
- Local brand name: ADVIL DUAL ACTION WITH ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 August 2020
- Application: ANDA213255
- Marketing authorisation holder: MYLAN
- Local brand name: ACETAMINOPHEN
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 18 February 2021
- Application: NDA204957
- Marketing authorisation holder: B BRAUN MEDICAL
- Local brand name: ACETAMINOPHEN
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 23 February 2021
- Application: ANDA214039
- Marketing authorisation holder: GRANULES
- Local brand name: ACETAMINOPHEN, ASPIRIN AND CAFFEINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 September 2021
- Application: ANDA214331
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Local brand name: ACETAMINOPHEN
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 2 February 2022
- Application: ANDA211695
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: ACETAMINOPHEN, ASPIRIN AND CAFFEINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 April 2022
- Application: ANDA214088
- Marketing authorisation holder: SENORES PHARMS
- Local brand name: BUTALBITAL AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 June 2022
- Application: NDA206968
- Marketing authorisation holder: HIKMA
- Local brand name: ACETAMINOPHEN
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 27 July 2022
- Application: ANDA216617
- Marketing authorisation holder: ASPIRO
- Local brand name: ACETAMINOPHEN
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 16 August 2022
- Application: ANDA214955
- Marketing authorisation holder: NE RX PHARMA
- Local brand name: BUTALBITAL AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 October 2022
- Application: ANDA216467
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: ACETAMINOPHEN
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 1 March 2023
- Application: NDA209471
- Marketing authorisation holder: AFT PHARMS US
- Local brand name: COMBOGESIC
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 April 2023
- Application: ANDA205746
- Marketing authorisation holder: WOCKHARDT BIO AG
- Local brand name: ACETAMINOPHEN
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 3 May 2023
- Application: ANDA215403
- Marketing authorisation holder: INFORLIFE
- Local brand name: ACETAMINOPHEN
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 17 October 2023
- Application: NDA215320
- Marketing authorisation holder: HIKMA
- Local brand name: COMBOGESIC IV
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 1 February 2024
- Application: ANDA214305
- Marketing authorisation holder: QUAGEN
- Local brand name: BUTALBITAL AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 April 2025
- Application: ANDA219215
- Marketing authorisation holder: GLAND
- Local brand name: ACETAMINOPHEN
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 5 December 2025
- Application: ANDA219096
- Marketing authorisation holder: CAPLIN
- Local brand name: ACETAMINOPHEN
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA083951
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: EMPRACET W/ CODEINE PHOSPHATE #4
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA089568
- Marketing authorisation holder: HALSEY
- Local brand name: BUTALBITAL AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA089023
- Marketing authorisation holder: MALLINCKRODT
- Local brand name: TRIAD
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA085685
- Marketing authorisation holder: SOLVAY
- Local brand name: PROVAL #3
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA073106
- Marketing authorisation holder: ABLE
- Local brand name: ACETAMINOPHEN
- Indication: SUPPOSITORY — RECTAL
- Status: approved
FDA
- Application: ANDA085676
- Marketing authorisation holder: VITARINE
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088889
- Marketing authorisation holder: FOREST PHARMS
- Local brand name: BANCAP
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA070107
- Marketing authorisation holder: TEVA
- Local brand name: PROPACET 100
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA073107
- Marketing authorisation holder: ABLE
- Local brand name: ACETAMINOPHEN
- Indication: SUPPOSITORY — RECTAL
- Status: approved
FDA
- Application: ANDA207113
- Marketing authorisation holder: ACTAVIS LABS FL INC
- Local brand name: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA089360
- Marketing authorisation holder: CENT PHARMS
- Local brand name: CO-GESIC
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA070732
- Marketing authorisation holder: TEVA
- Local brand name: PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA089660
- Marketing authorisation holder: FOREST PHARMS
- Local brand name: ESGIC
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA072106
- Marketing authorisation holder: HALSEY
- Local brand name: PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085100
- Marketing authorisation holder: LEDERLE
- Local brand name: DOLENE AP-65
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA089115
- Marketing authorisation holder: US CHEM
- Local brand name: MEDIGESIC PLUS
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA073108
- Marketing authorisation holder: ABLE
- Local brand name: ACETAMINOPHEN
- Indication: SUPPOSITORY — RECTAL
- Status: approved
FDA
- Application: ANDA070399
- Marketing authorisation holder: WATSON LABS
- Local brand name: PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA089102
- Marketing authorisation holder: MALLINCKRODT
- Local brand name: FEMCET
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA070398
- Marketing authorisation holder: WATSON LABS
- Local brand name: PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA017785
- Marketing authorisation holder: ORTHO MCNEIL PHARM
- Local brand name: INJECTAPAP
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA086549
- Marketing authorisation holder: HALSEY
- Local brand name: ACETAMINOPHEN AND CODEINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
Other Immunology approved in United States
Frequently asked questions
Is Acetaminophen approved in United States?
Yes. FDA authorised it on 7 November 1968; FDA authorised it on 18 October 1972; FDA authorised it on 31 May 1974.
Who is the marketing authorisation holder for Acetaminophen in United States?
POLYMEDICA holds the US marketing authorisation.