FDA — authorised 2 November 1981
- Application: ANDA087406
- Marketing authorisation holder: BARR
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Oxycodone and acetaminophen in United States
FDA authorised Oxycodone and acetaminophen on 2 November 1981 · 10,617 US adverse-event reports
Marketing authorisations
FDA — authorised 4 May 1989
- Application: ANDA089994
- Marketing authorisation holder: HALSEY
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 July 1996
- Application: ANDA040105
- Marketing authorisation holder: PH HEALTH
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 July 1996
- Application: ANDA040106
- Marketing authorisation holder: VINTAGE PHARMS
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 October 1997
- Application: ANDA040234
- Marketing authorisation holder: WATSON LABS
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 January 1998
- Application: ANDA040219
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 June 1998
- Application: ANDA040272
- Marketing authorisation holder: DURAMED PHARMS BARR
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 August 1998
- Application: ANDA040257
- Marketing authorisation holder: MALLINCKRODT
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 15 March 1999
- Application: ANDA040203
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 March 1999
- Application: ANDA040289
- Marketing authorisation holder: DURAMED PHARMS BARR
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 December 1999
- Application: ANDA040303
- Marketing authorisation holder: VINTAGE PHARMS LLC
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 October 2000
- Application: ANDA040304
- Marketing authorisation holder: BARR
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 December 2000
- Application: ANDA040371
- Marketing authorisation holder: WATSON LABS
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 September 2003
- Application: ANDA040535
- Marketing authorisation holder: WATSON LABS
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 June 2004
- Application: ANDA040550
- Marketing authorisation holder: MALLINCKRODT
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 June 2004
- Application: ANDA040545
- Marketing authorisation holder: SPECGX LLC
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 December 2005
- Application: ANDA040608
- Marketing authorisation holder: MIKART
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 April 2006
- Application: ANDA040676
- Marketing authorisation holder: MIKART
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 April 2006
- Application: ANDA040698
- Marketing authorisation holder: MIKART
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 April 2006
- Application: ANDA040692
- Marketing authorisation holder: MIKART
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 April 2006
- Application: ANDA040687
- Marketing authorisation holder: MIKART
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 May 2006
- Application: ANDA040679
- Marketing authorisation holder: MIKART
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 September 2006
- Application: ANDA040680
- Marketing authorisation holder: SPECGX LLC
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 20 October 2008
- Application: ANDA090177
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 July 2012
- Application: ANDA202677
- Marketing authorisation holder: ALVOGEN
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 July 2013
- Application: ANDA201972
- Marketing authorisation holder: AUROLIFE PHARMA LLC
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 December 2013
- Application: ANDA090535
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 August 2014
- Application: ANDA201278
- Marketing authorisation holder: RHODES PHARMS
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 December 2016
- Application: ANDA207574
- Marketing authorisation holder: SANALUZ
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 February 2017
- Application: ANDA204407
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 March 2017
- Application: ANDA207419
- Marketing authorisation holder: ASCENT PHARMS INC
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 September 2017
- Application: ANDA207333
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 December 2017
- Application: ANDA210079
- Marketing authorisation holder: NESHER PHARMS
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 February 2018
- Application: ANDA210644
- Marketing authorisation holder: ABHAI LLC
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 March 2018
- Application: ANDA207510
- Marketing authorisation holder: WES PHARMA INC
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 July 2018
- Application: ANDA209385
- Marketing authorisation holder: ELITE LABS INC
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 July 2018
- Application: ANDA203864
- Marketing authorisation holder: EPIC PHARMA LLC
- Status: supplemented
FDA — authorised 27 November 2018
- Application: ANDA202142
- Marketing authorisation holder: MIKART
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 31 December 2018
- Application: ANDA211499
- Marketing authorisation holder: ABHAI LLC
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 15 August 2019
- Application: ANDA207834
- Marketing authorisation holder: CHARTWELL
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 October 2019
- Application: ANDA211708
- Marketing authorisation holder: GRANULES
- Local brand name: OXYCODONE AND ACETAMINOPHEN
- Indication: TABLET — ORAL
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 22 April 2025 – 22 April 2026
- Total reports: 10,617
Most-reported reactions
- Pain — 1,457 reports (13.72%)
- Fatigue — 1,415 reports (13.33%)
- Drug Ineffective — 1,414 reports (13.32%)
- Dyspnoea — 1,029 reports (9.69%)
- Arthralgia — 947 reports (8.92%)
- Nausea — 938 reports (8.83%)
- Headache — 890 reports (8.38%)
- Rash — 867 reports (8.17%)
- Pruritus — 843 reports (7.94%)
- Pyrexia — 817 reports (7.7%)
Other Pain Management approved in United States
Frequently asked questions
Is Oxycodone and acetaminophen approved in United States?
Yes. FDA authorised it on 2 November 1981; FDA authorised it on 4 May 1989; FDA authorised it on 30 July 1996.
Who is the marketing authorisation holder for Oxycodone and acetaminophen in United States?
BARR holds the US marketing authorisation.