FDA — authorised 18 September 1984
- Application: NDA018565
- Marketing authorisation holder: HIKMA
- Local brand name: DURAMORPH PF
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Duramorph Pf in United States
FDA authorised Duramorph Pf on 18 September 1984
Marketing authorisations
FDA — authorised 11 May 1988
- Application: ANDA071850
- Marketing authorisation holder: HOSPIRA
- Local brand name: MORPHINE SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 May 1988
- Application: ANDA071849
- Marketing authorisation holder: HOSPIRA
- Local brand name: MORPHINE SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 July 1990
- Application: NDA019999
- Marketing authorisation holder: MERIDIAN MEDCL TECHN
- Local brand name: MORPHINE SULFATE (AUTOINJECTOR)
- Indication: SOLUTION — INTRAMUSCULAR
- Status: approved
FDA — authorised 15 August 1991
- Application: NDA019977
- Marketing authorisation holder: XANODYNE PHARMS INC
- Local brand name: ORAMORPH SR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 30 September 1991
- Application: ANDA073373
- Marketing authorisation holder: WATSON LABS
- Local brand name: MORPHINE SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 September 1991
- Application: ANDA073376
- Marketing authorisation holder: WATSON LABS
- Local brand name: MORPHINE SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 September 1991
- Application: ANDA073375
- Marketing authorisation holder: WATSON LABS
- Local brand name: MORPHINE SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 September 1991
- Application: ANDA073374
- Marketing authorisation holder: WATSON LABS
- Local brand name: MORPHINE SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 September 1992
- Application: ANDA073509
- Marketing authorisation holder: HOSPIRA
- Local brand name: MORPHINE SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 September 1992
- Application: ANDA073510
- Marketing authorisation holder: HOSPIRA
- Local brand name: MORPHINE SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 October 1992
- Application: NDA019916
- Marketing authorisation holder: ICU MEDICAL INC
- Local brand name: MORPHINE SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 October 1992
- Application: NDA019917
- Marketing authorisation holder: ICU MEDICAL INC
- Local brand name: MORPHINE SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 July 1996
- Application: NDA020631
- Marketing authorisation holder: SPECGX LLC
- Local brand name: MORPHINE SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 July 1998
- Application: ANDA074862
- Marketing authorisation holder: RHODES PHARMS
- Local brand name: MORPHINE SULFATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 28 October 1998
- Application: ANDA075295
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: MORPHINE SULFATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 30 January 2001
- Application: ANDA075656
- Marketing authorisation holder: WATSON LABS
- Local brand name: MORPHINE SULFATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 19 May 2004
- Application: ANDA076733
- Marketing authorisation holder: NESHER PHARMS
- Local brand name: MORPHINE SULFATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 27 September 2007
- Application: ANDA077855
- Marketing authorisation holder: NESHER PHARMS
- Local brand name: MORPHINE SULFATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 17 March 2008
- Application: NDA022195
- Marketing authorisation holder: HIKMA
- Local brand name: MORPHINE SULFATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 17 March 2008
- Application: NDA022207
- Marketing authorisation holder: HIKMA
- Local brand name: MORPHINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 June 2011
- Application: NDA201517
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: MORPHINE SULFATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 15 July 2011
- Application: ANDA202348
- Marketing authorisation holder: SPECGX LLC
- Local brand name: MORPHINE SULFATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 18 October 2011
- Application: ANDA200824
- Marketing authorisation holder: RISING
- Local brand name: MORPHINE SULFATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 10 November 2011
- Application: ANDA200812
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: MORPHINE SULFATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 14 November 2011
- Application: NDA202515
- Marketing authorisation holder: HOSPIRA INC
- Local brand name: MORPHINE SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 5 January 2012
- Application: ANDA201947
- Marketing authorisation holder: VISTAPHARM
- Local brand name: MORPHINE SULFATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 6 August 2012
- Application: ANDA201574
- Marketing authorisation holder: PADAGIS US
- Local brand name: MORPHINE SULFATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 28 September 2012
- Application: ANDA074769
- Marketing authorisation holder: RHODES PHARMS
- Indication: Labeling
- Status: approved
FDA — authorised 16 January 2013
- Application: ANDA079040
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: MORPHINE SULFATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 3 June 2013
- Application: ANDA202104
- Marketing authorisation holder: UPSHER SMITH LABS
- Local brand name: MORPHINE SULFATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 30 October 2013
- Application: NDA204223
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: MORPHINE SULFATE
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS
- Status: approved
FDA — authorised 5 February 2014
- Application: ANDA201011
- Marketing authorisation holder: SANKALP LIFECARE
- Local brand name: MORPHINE SULFATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 29 December 2014
- Application: ANDA202718
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: MORPHINE SULFATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 6 April 2015
- Application: ANDA203849
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: MORPHINE SULFATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 21 May 2015
- Application: ANDA205758
- Marketing authorisation holder: HIKMA
- Local brand name: MORPHINE SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 October 2015
- Application: ANDA202310
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: MORPHINE SULFATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 25 November 2015
- Application: ANDA202309
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: MORPHINE SULFATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 16 December 2015
- Application: ANDA203602
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: MORPHINE SULFATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 12 April 2016
- Application: ANDA200411
- Marketing authorisation holder: IMPAX LABS INC
- Local brand name: MORPHINE SULFATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 23 June 2016
- Application: ANDA091357
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: MORPHINE SULFATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 12 July 2016
- Application: ANDA206420
- Marketing authorisation holder: RHODES PHARMS
- Local brand name: MORPHINE SULFATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 25 August 2016
- Application: ANDA205634
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: MORPHINE SULFATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 28 October 2016
- Application: ANDA205386
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: MORPHINE SULFATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 14 November 2016
- Application: ANDA206573
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: MORPHINE SULFATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 9 January 2017
- Application: NDA208603
- Marketing authorisation holder: ZYLA
- Local brand name: ARYMO ER
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 22 June 2017
- Application: ANDA206308
- Marketing authorisation holder: RHODES PHARMS
- Local brand name: MORPHINE SULFATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 6 July 2017
- Application: ANDA208809
- Marketing authorisation holder: HIKMA
- Local brand name: MORPHINE SULFATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 17 April 2018
- Application: ANDA205509
- Marketing authorisation holder: ANI PHARMS
- Local brand name: MORPHINE SULFATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 16 July 2018
- Application: ANDA204393
- Marketing authorisation holder: PIRAMAL CRITICAL
- Local brand name: MITIGO
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 December 2020
- Application: ANDA212451
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: MORPHINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 February 2021
- Application: ANDA211454
- Marketing authorisation holder: WINDER LABS LLC
- Local brand name: MORPHINE SULFATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 29 April 2021
- Application: ANDA202861
- Marketing authorisation holder: INTL MEDICATION SYS
- Local brand name: MORPHINE SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 August 2021
- Application: ANDA203158
- Marketing authorisation holder: ANDA REPOSITORY
- Local brand name: MORPHINE SULFATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 12 January 2022
- Application: ANDA207270
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: MORPHINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 February 2022
- Application: ANDA215584
- Marketing authorisation holder: INGENUS PHARMS NJ
- Local brand name: MORPHINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 January 2023
- Application: ANDA211452
- Marketing authorisation holder: HIKMA
- Local brand name: MORPHINE SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 August 2023
- Application: ANDA215194
- Marketing authorisation holder: SPECGX LLC
- Local brand name: MORPHINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
Duramorph Pf in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Duramorph Pf approved in United States?
Yes. FDA authorised it on 18 September 1984; FDA authorised it on 11 May 1988; FDA authorised it on 11 May 1988.
Who is the marketing authorisation holder for Duramorph Pf in United States?
HIKMA holds the US marketing authorisation.