FDA — authorised 21 May 1981
- Application: NDA018197
- Marketing authorisation holder: BASF
- Local brand name: RUFEN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 SST-0225 Topical Ibuprofen Cream in United States
FDA authorised SST-0225 Topical Ibuprofen Cream on 21 May 1981
Marketing authorisations
FDA — authorised 24 July 1985
- Application: ANDA070079
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 July 1985
- Application: ANDA070080
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 August 1985
- Application: ANDA070329
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 August 1985
- Application: ANDA070330
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 August 1985
- Application: ANDA070436
- Marketing authorisation holder: WATSON LABS
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 August 1985
- Application: ANDA070437
- Marketing authorisation holder: WATSON LABS
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 August 1985
- Application: ANDA070469
- Marketing authorisation holder: OHM LABS
- Local brand name: IBUPROHM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 September 1985
- Application: ANDA070045
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 September 1985
- Application: ANDA070057
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 October 1985
- Application: ANDA070481
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 December 1985
- Application: ANDA070493
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 December 1985
- Application: ANDA070818
- Marketing authorisation holder: OHM LABS
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 March 1986
- Application: ANDA070435
- Marketing authorisation holder: WATSON LABS
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 April 1986
- Application: ANDA070709
- Marketing authorisation holder: SUPERPHARM
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 May 1986
- Application: ANDA070475
- Marketing authorisation holder: MCNEIL
- Local brand name: MEDIPREN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 June 1986
- Application: ANDA070736
- Marketing authorisation holder: RISING
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 June 1986
- Application: ANDA070081
- Marketing authorisation holder: J AND J CONSUMER INC
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 July 1986
- Application: ANDA071163
- Marketing authorisation holder: OHM
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 July 1986
- Application: ANDA070986
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 September 1986
- Application: ANDA070630
- Marketing authorisation holder: LEDERLE
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 September 1986
- Application: ANDA070733
- Marketing authorisation holder: P AND L DEV LLC
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 September 1986
- Application: ANDA070629
- Marketing authorisation holder: LEDERLE
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 September 1986
- Application: ANDA071146
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 September 1986
- Application: ANDA071145
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 October 1986
- Application: ANDA071462
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 October 1986
- Application: ANDA071265
- Marketing authorisation holder: ADAPTIS
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 October 1986
- Application: ANDA071266
- Marketing authorisation holder: LEINER
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 October 1986
- Application: ANDA071267
- Marketing authorisation holder: CONTRACT PHARMACAL
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 October 1986
- Application: ANDA071268
- Marketing authorisation holder: CONTRACT PHARMACAL
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 November 1986
- Application: ANDA071334
- Marketing authorisation holder: AMNEAL PHARMS NY
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 November 1986
- Application: ANDA071335
- Marketing authorisation holder: AMNEAL PHARMS NY
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 December 1986
- Application: ANDA071338
- Marketing authorisation holder: WATSON LABS
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 January 1987
- Application: ANDA071144
- Marketing authorisation holder: ANI PHARMS
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 February 1987
- Application: ANDA071333
- Marketing authorisation holder: AMNEAL PHARMS NY
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 February 1987
- Application: ANDA071448
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 May 1987
- Application: ANDA071769
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 May 1987
- Application: ANDA071065
- Marketing authorisation holder: LEDERLE
- Local brand name: ACHES-N-PAIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 June 1987
- Application: ANDA071668
- Marketing authorisation holder: PLIVA
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 June 1987
- Application: ANDA071666
- Marketing authorisation holder: PLIVA
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 June 1987
- Application: ANDA071667
- Marketing authorisation holder: PLIVA
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 July 1987
- Application: ANDA071547
- Marketing authorisation holder: WATSON LABS
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 July 1987
- Application: ANDA071773
- Marketing authorisation holder: PLIVA
- Local brand name: IBUPRIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 September 1987
- Application: ANDA071765
- Marketing authorisation holder: WATSON LABS
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 September 1987
- Application: ANDA071735
- Marketing authorisation holder: CONTRACT PHARMACAL
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 October 1987
- Application: ANDA070985
- Marketing authorisation holder: MERRO PHARM
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 October 1987
- Application: ANDA071935
- Marketing authorisation holder: AMNEAL PHARMS NY
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 December 1987
- Application: ANDA072098
- Marketing authorisation holder: PERRIGO
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 December 1987
- Application: ANDA072097
- Marketing authorisation holder: PERRIGO
- Local brand name: CAP-PROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 December 1987
- Application: ANDA072096
- Marketing authorisation holder: PERRIGO
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 December 1987
- Application: ANDA072095
- Marketing authorisation holder: PERRIGO
- Local brand name: TAB-PROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 December 1987
- Application: ANDA072169
- Marketing authorisation holder: SANDOZ
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 January 1988
- Application: ANDA072065
- Marketing authorisation holder: SANDOZ
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 February 1988
- Application: ANDA071644
- Marketing authorisation holder: PH HEALTH
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 February 1988
- Application: ANDA071639
- Marketing authorisation holder: PH HEALTH
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 February 1988
- Application: ANDA072035
- Marketing authorisation holder: BRISTOL MYERS
- Local brand name: NUPRIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 February 1988
- Application: ANDA072036
- Marketing authorisation holder: BRISTOL MYERS
- Local brand name: NUPRIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 February 1988
- Application: ANDA071807
- Marketing authorisation holder: SANDOZ
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 May 1988
- Application: ANDA071870
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 May 1988
- Application: ANDA072199
- Marketing authorisation holder: AMNEAL PHARMS NY
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 July 1988
- Application: ANDA072299
- Marketing authorisation holder: ADAPTIS
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 July 1988
- Application: ANDA072300
- Marketing authorisation holder: CONTRACT PHARMACAL
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 August 1988
- Application: ANDA071057
- Marketing authorisation holder: ALRA
- Local brand name: IBU-TAB 200
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 August 1988
- Application: ANDA071059
- Marketing authorisation holder: ALRA
- Local brand name: IBU-TAB
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 August 1988
- Application: ANDA071058
- Marketing authorisation holder: ALRA
- Local brand name: IBU-TAB
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 December 1988
- Application: ANDA070476
- Marketing authorisation holder: MCNEIL
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 January 1989
- Application: ANDA072249
- Marketing authorisation holder: PH HEALTH
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 September 1989
- Application: NDA019833
- Marketing authorisation holder: HALEON US HOLDINGS
- Local brand name: CHILDREN'S ADVIL
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 19 December 1991
- Application: ANDA072903
- Marketing authorisation holder: ANI PHARMS
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 December 1991
- Application: ANDA072901
- Marketing authorisation holder: ANI PHARMS
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 June 1992
- Application: ANDA073345
- Marketing authorisation holder: TEVA
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 June 1992
- Application: ANDA073343
- Marketing authorisation holder: TEVA
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 June 1992
- Application: ANDA073344
- Marketing authorisation holder: TEVA
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 December 1992
- Application: NDA019899
- Marketing authorisation holder: KENVUE BRANDS
- Local brand name: SINE-AID IB
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 February 1994
- Application: ANDA073691
- Marketing authorisation holder: CONTRACT PHARMACAL
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 March 1994
- Application: ANDA073019
- Marketing authorisation holder: MCNEIL
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 April 1995
- Application: NDA020402
- Marketing authorisation holder: HALEON US HOLDINGS
- Local brand name: ADVIL MIGRAINE LIQUI-GELS
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 15 December 1995
- Application: ANDA074533
- Marketing authorisation holder: SANDOZ
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 December 1995
- Application: ANDA074525
- Marketing authorisation holder: SANDOZ
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 June 1996
- Application: NDA020602
- Marketing authorisation holder: KENVUE BRANDS
- Local brand name: JUNIOR STRENGTH MOTRIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 June 1996
- Application: NDA020589
- Marketing authorisation holder: HALEON US HOLDINGS
- Local brand name: CHILDREN'S ADVIL
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 15 November 1996
- Application: NDA020601
- Marketing authorisation holder: KENVUE BRANDS
- Local brand name: JUNIOR STRENGTH MOTRIN
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 13 December 1996
- Application: NDA020267
- Marketing authorisation holder: HALEON US HOLDINGS
- Local brand name: JUNIOR STRENGTH ADVIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 January 1998
- Application: NDA020812
- Marketing authorisation holder: HALEON US HOLDINGS
- Local brand name: PEDIATRIC ADVIL
- Indication: SUSPENSION/DROPS — ORAL
- Status: approved
FDA — authorised 25 March 1998
- Application: ANDA074978
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: IBUPROFEN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 20 July 1998
- Application: ANDA074931
- Marketing authorisation holder: CONTRACT PHARMACAL
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 July 1998
- Application: ANDA071905
- Marketing authorisation holder: WATSON LABS
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 December 1998
- Application: ANDA075217
- Marketing authorisation holder: L PERRIGO CO
- Local brand name: IBUPROFEN
- Indication: SUSPENSION/DROPS — ORAL
- Status: approved
FDA — authorised 18 December 1998
- Application: NDA020944
- Marketing authorisation holder: HALEON US HOLDINGS
- Local brand name: JUNIOR STRENGTH ADVIL
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 22 December 1998
- Application: ANDA074937
- Marketing authorisation holder: PERRIGO
- Local brand name: CHILDREN'S IBUPROFEN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 1 March 1999
- Application: ANDA075139
- Marketing authorisation holder: LNK
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 March 1999
- Application: ANDA075010
- Marketing authorisation holder: LNK
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 April 1999
- Application: ANDA075367
- Marketing authorisation holder: L PERRIGO CO
- Local brand name: JUNIOR STRENGTH IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 April 1999
- Application: ANDA074916
- Marketing authorisation holder: P AND L
- Local brand name: IBUPROFEN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 1 August 2000
- Application: NDA021128
- Marketing authorisation holder: KENVUE BRANDS
- Local brand name: CHILDREN'S MOTRIN COLD
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 17 April 2001
- Application: ANDA074567
- Marketing authorisation holder: OHM LABS
- Local brand name: IBUPROHM COLD AND SINUS
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 October 2001
- Application: ANDA076112
- Marketing authorisation holder: DR REDDYS LABS INC
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 November 2001
- Application: ANDA075682
- Marketing authorisation holder: DR REDDYS
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 November 2001
- Application: ANDA076117
- Marketing authorisation holder: DR REDDYS LABS INC
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 December 2001
- Application: ANDA075661
- Marketing authorisation holder: DR REDDYS
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 April 2002
- Application: ANDA075588
- Marketing authorisation holder: CONTRACT PHARMACAL
- Local brand name: IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 April 2002
- Application: NDA021373
- Marketing authorisation holder: HALEON US HOLDINGS
- Local brand name: CHILDREN'S ADVIL COLD
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 18 October 2002
- Application: NDA021472
- Marketing authorisation holder: BIONPHARMA
- Local brand name: MIDOL LIQUID GELS
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 5 November 2003
- Application: ANDA076478
- Marketing authorisation holder: PERRIGO
- Local brand name: IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 26 November 2003
- Application: ANDA076460
- Marketing authorisation holder: AVEMA PHARMA
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 January 2004
- Application: NDA021604
- Marketing authorisation holder: MOBERG PHARMA NORTH
- Local brand name: CHILDREN'S ELIXSURE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 16 January 2004
- Application: ANDA076359
- Marketing authorisation holder: PERRIGO
- Local brand name: IBUPROFEN
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 17 June 2004
- Application: ANDA076741
- Marketing authorisation holder: LNK
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 September 2004
- Application: ANDA076925
- Marketing authorisation holder: PADAGIS US
- Local brand name: IBUPROFEN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 26 November 2004
- Application: NDA021378
- Marketing authorisation holder: FOREST LABS
- Local brand name: COMBUNOX
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 June 2005
- Application: ANDA077349
- Marketing authorisation holder: PERRIGO R AND D
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 July 2005
- Application: ANDA077114
- Marketing authorisation holder: L PERRIGO CO
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 August 2006
- Application: ANDA077628
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 June 2007
- Application: ANDA078558
- Marketing authorisation holder: AMNEAL PHARMS NY
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 September 2007
- Application: ANDA078132
- Marketing authorisation holder: NORTHSTAR HLTHCARE
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 November 2007
- Application: ANDA078394
- Marketing authorisation holder: WATSON LABS
- Local brand name: OXYCODONE HYDROCHLORIDE AND IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 November 2007
- Application: ANDA078316
- Marketing authorisation holder: BARR LABS INC
- Local brand name: OXYCODONE HYDROCHLORIDE AND IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 February 2009
- Application: ANDA078329
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 March 2009
- Application: ANDA078682
- Marketing authorisation holder: BIONPHARMA
- Local brand name: IBUPROFEN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 26 June 2009
- Application: ANDA079205
- Marketing authorisation holder: MARKSANS PHARMA
- Local brand name: IBUPROFEN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 July 2009
- Application: ANDA077338
- Marketing authorisation holder: P AND L DEV LLC
- Local brand name: IBUPROFEN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 31 August 2009
- Application: ANDA079058
- Marketing authorisation holder: TRIS PHARMA INC
- Local brand name: IBUPROFEN
- Indication: SUSPENSION/DROPS — ORAL
- Status: approved
FDA — authorised 10 December 2010
- Application: ANDA079174
- Marketing authorisation holder: GRANULES INDIA
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 December 2010
- Application: ANDA090796
- Marketing authorisation holder: MARKSANS PHARMA
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 February 2011
- Application: ANDA091239
- Marketing authorisation holder: MARKSANS PHARMA
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 February 2011
- Application: ANDA091237
- Marketing authorisation holder: MARKSANS PHARMA
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 March 2011
- Application: ANDA079129
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 April 2011
- Application: ANDA091355
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 August 2011
- Application: ANDA200457
- Marketing authorisation holder: ARISE
- Local brand name: IBUPROFEN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 23 December 2011
- Application: ANDA202300
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: IBUPROFEN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 March 2014
- Application: ANDA079233
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 July 2014
- Application: ANDA203200
- Marketing authorisation holder: PERRIGO R AND D
- Local brand name: IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 September 2015
- Application: ANDA091625
- Marketing authorisation holder: GRANULES
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 June 2016
- Application: ANDA206568
- Marketing authorisation holder: HUMANWELL PURACAP
- Local brand name: IBUPROFEN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 7 September 2016
- Application: ANDA203599
- Marketing authorisation holder: SOFGEN PHARMS
- Local brand name: IBUPROFEN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 7 October 2016
- Application: ANDA202312
- Marketing authorisation holder: GRANULES
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 November 2016
- Application: ANDA205647
- Marketing authorisation holder: PAI HOLDINGS PHARM
- Local brand name: IBUPROFEN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 5 May 2017
- Application: ANDA207095
- Marketing authorisation holder: SHANDONG XINHUA
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 May 2017
- Application: ANDA207052
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 June 2017
- Application: ANDA209204
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: IBUPROFEN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 27 June 2017
- Application: ANDA209207
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: IBUPROFEN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 16 February 2018
- Application: ANDA209178
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: IBUPROFEN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 28 March 2018
- Application: ANDA204469
- Marketing authorisation holder: ONESOURCE SPECIALTY
- Local brand name: IBUPROFEN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 17 April 2018
- Application: ANDA209179
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: IBUPROFEN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 17 August 2018
- Application: ANDA210149
- Marketing authorisation holder: GUARDIAN DRUG
- Local brand name: IBUPROFEN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 10 September 2018
- Application: ANDA204062
- Marketing authorisation holder: SUNSHINE
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 September 2018
- Application: ANDA210755
- Marketing authorisation holder: GUARDIAN DRUG
- Local brand name: IBUPROFEN
- Indication: SUSPENSION/DROPS — ORAL
- Status: approved
FDA — authorised 6 January 2020
- Application: ANDA209076
- Marketing authorisation holder: ULTRATAB LABS INC
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 May 2020
- Application: ANDA213794
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 October 2020
- Application: ANDA214003
- Marketing authorisation holder: YICHANG HUMANWELL
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 February 2021
- Application: ANDA211666
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: IBUPROFEN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 13 September 2021
- Application: ANDA214699
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 March 2022
- Application: ANDA215318
- Marketing authorisation holder: YICHANG HUMANWELL
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 May 2022
- Application: ANDA215311
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: IBUPROFEN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 9 June 2022
- Application: ANDA214071
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: IBUPROFEN
- Indication: SUSPENSION/DROPS — ORAL
- Status: approved
FDA — authorised 10 March 2023
- Application: ANDA213565
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 September 2023
- Application: ANDA215777
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: IBUPROFEN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 8 April 2024
- Application: ANDA213506
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: IBUPROFEN
- Indication: SUSPENSION/DROPS — ORAL
- Status: approved
FDA — authorised 8 November 2024
- Application: ANDA214789
- Marketing authorisation holder: PAI HOLDINGS PHARM
- Local brand name: IBUPROFEN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 5 March 2026
- Application: ANDA220239
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: IBUPROFEN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA
- Application: ANDA071027
- Marketing authorisation holder: HALSEY
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA072064
- Marketing authorisation holder: SANDOZ
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071001
- Marketing authorisation holder: BAYER
- Local brand name: MIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071028
- Marketing authorisation holder: HALSEY
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA072040
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070041
- Marketing authorisation holder: WATSON LABS
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071154
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071964
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071002
- Marketing authorisation holder: BAYER
- Local brand name: MIDOL
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA071029
- Marketing authorisation holder: HALSEY
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071030
- Marketing authorisation holder: HALSEY
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071911
- Marketing authorisation holder: WATSON LABS
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA072137
- Marketing authorisation holder: HALSEY
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071122
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071938
- Marketing authorisation holder: RISING
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071264
- Marketing authorisation holder: ABBOTT
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070038
- Marketing authorisation holder: WATSON LABS
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071124
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071125
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070626
- Marketing authorisation holder: BAYER
- Local brand name: MIDOL
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA071664
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071123
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070328
- Marketing authorisation holder: PAR PHARM
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070556
- Marketing authorisation holder: ABBOTT
- Local brand name: IBUPROFEN
- Indication: TABLET — ORAL
- Status: approved
Other Pain Management approved in United States
Frequently asked questions
Is SST-0225 Topical Ibuprofen Cream approved in United States?
Yes. FDA authorised it on 21 May 1981; FDA authorised it on 24 July 1985; FDA authorised it on 24 July 1985.
Who is the marketing authorisation holder for SST-0225 Topical Ibuprofen Cream in United States?
BASF holds the US marketing authorisation.