FDA — authorised 6 February 2004
- Application: ANDA076636
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Pharmacologic Pain Management in United States
FDA authorised Pharmacologic Pain Management on 6 February 2004
Marketing authorisations
FDA — authorised 25 May 2004
- Application: ANDA076168
- Marketing authorisation holder: TEVA
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 30 June 2004
- Application: ANDA076758
- Marketing authorisation holder: SPECGX LLC
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 January 2007
- Application: ANDA077712
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 July 2008
- Application: ANDA077822
- Marketing authorisation holder: MALLINCKRODT
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 10 April 2009
- Application: ANDA090659
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 August 2009
- Application: ANDA090895
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 February 2011
- Application: ANDA091313
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 March 2011
- Application: ANDA091490
- Marketing authorisation holder: RHODES PHARMS
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 December 2011
- Application: ANDA202116
- Marketing authorisation holder: ALVOGEN
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 January 2012
- Application: NDA201194
- Marketing authorisation holder: VISTAPHARM LLC
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 30 July 2012
- Application: ANDA202537
- Marketing authorisation holder: VISTAPHARM LLC
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 19 November 2012
- Application: ANDA202160
- Marketing authorisation holder: AUROLIFE PHARMA LLC
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 July 2013
- Application: ANDA203208
- Marketing authorisation holder: HIKMA
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 15 July 2013
- Application: ANDA204037
- Marketing authorisation holder: HIKMA
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 3 June 2014
- Application: ANDA203638
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 June 2014
- Application: ANDA204092
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 1 August 2014
- Application: ANDA203823
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 September 2014
- Application: ANDA204085
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 29 April 2015
- Application: ANDA204603
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 1 June 2015
- Application: ANDA204979
- Marketing authorisation holder: ANI PHARMS
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 16 June 2015
- Application: ANDA206456
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 24 August 2015
- Application: ANDA204752
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 September 2015
- Application: ANDA202662
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 March 2016
- Application: ANDA205177
- Marketing authorisation holder: ANI PHARMS
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 12 April 2016
- Application: ANDA207119
- Marketing authorisation holder: NUVO PHARM
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 November 2016
- Application: ANDA207511
- Marketing authorisation holder: HIBROW HLTHCARE
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 20 April 2017
- Application: NDA209777
- Marketing authorisation holder: PROTEGA PHARMS
- Local brand name: ROXYBOND
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 June 2017
- Application: ANDA204021
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 July 2017
- Application: ANDA208593
- Marketing authorisation holder: ABHAI LLC
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 7 August 2017
- Application: ANDA207418
- Marketing authorisation holder: ASCENT PHARMS INC
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 August 2017
- Application: ANDA208795
- Marketing authorisation holder: HIKMA
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 10 August 2017
- Application: ANDA208817
- Marketing authorisation holder: HIKMA
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 15 August 2017
- Application: ANDA206822
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 30 August 2017
- Application: ANDA203447
- Marketing authorisation holder: ANI PHARMS
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 6 September 2017
- Application: ANDA209897
- Marketing authorisation holder: HIBROW HLTHCARE
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 9 November 2017
- Application: ANDA209021
- Marketing authorisation holder: ASCENT PHARMS INC
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 30 April 2018
- Application: ANDA210758
- Marketing authorisation holder: SPECGX LLC
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 1 February 2019
- Application: ANDA206914
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 4 February 2019
- Application: ANDA211749
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 7 February 2019
- Application: ANDA211748
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 27 January 2020
- Application: ANDA212429
- Marketing authorisation holder: AUROLIFE PHARMA LLC
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 2 June 2021
- Application: ANDA213761
- Marketing authorisation holder: QUAGEN
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA
- Application: ANDA076318
- Marketing authorisation holder: IMPAX LABS
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA076610
- Marketing authorisation holder: TEVA
- Local brand name: OXYCODONE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
Pharmacologic Pain Management in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Pain Management approved in United States
Frequently asked questions
Is Pharmacologic Pain Management approved in United States?
Yes. FDA authorised it on 6 February 2004; FDA authorised it on 25 May 2004; FDA authorised it on 30 June 2004.
Who is the marketing authorisation holder for Pharmacologic Pain Management in United States?
ACTAVIS ELIZABETH holds the US marketing authorisation.