FDA — authorised 2 July 1986
- Application: ANDA070751
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: NALBUPHINE HYDROCHLORIDE
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Status: approved
🇺🇸 NALBUPHINE HYDROCHLORIDE in United States
FDA authorised NALBUPHINE HYDROCHLORIDE on 2 July 1986
Marketing authorisations
FDA — authorised 3 February 1989
- Application: ANDA070915
- Marketing authorisation holder: HOSPIRA
- Status: approved
FDA — authorised 12 March 1993
- Application: NDA020200
- Marketing authorisation holder: ABBVIE
- Local brand name: NALBUPHINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 February 1997
- Application: ANDA070918
- Marketing authorisation holder: HOSPIRA
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 11 January 2019
- Application: ANDA207595
- Marketing authorisation holder: RISING
- Local brand name: NALBUPHINE HYDROCHLORIDE
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA — authorised 6 February 2019
- Application: ANDA206506
- Marketing authorisation holder: RISING
- Local brand name: NALBUPHINE HYDROCHLORIDE
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA — authorised 1 December 2023
- Application: ANDA070914
- Marketing authorisation holder: HOSPIRA
- Indication: Labeling
- Status: approved
FDA — authorised 15 December 2023
- Application: ANDA070916
- Marketing authorisation holder: HOSPIRA
- Indication: Labeling
- Status: approved
FDA — authorised 19 September 2024
- Application: ANDA216049
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: NALBUPHINE HYDROCHLORIDE
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA — authorised 19 September 2024
- Application: ANDA216050
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: NALBUPHINE HYDROCHLORIDE
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA
- Application: ANDA072073
- Marketing authorisation holder: IGI LABS INC
- Local brand name: NALBUPHINE HYDROCHLORIDE
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA
- Application: ANDA072071
- Marketing authorisation holder: IGI LABS INC
- Local brand name: NALBUPHINE HYDROCHLORIDE
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA
- Application: ANDA072072
- Marketing authorisation holder: IGI LABS INC
- Local brand name: NALBUPHINE HYDROCHLORIDE
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA
- Application: ANDA072074
- Marketing authorisation holder: IGI LABS INC
- Local brand name: NALBUPHINE HYDROCHLORIDE
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA
- Application: ANDA072075
- Marketing authorisation holder: IGI LABS INC
- Local brand name: NALBUPHINE HYDROCHLORIDE
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA
- Application: ANDA072070
- Marketing authorisation holder: IGI LABS INC
- Local brand name: NALBUPHINE HYDROCHLORIDE
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Status: approved
NALBUPHINE HYDROCHLORIDE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is NALBUPHINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 2 July 1986; FDA authorised it on 3 February 1989; FDA authorised it on 12 March 1993.
Who is the marketing authorisation holder for NALBUPHINE HYDROCHLORIDE in United States?
ABRAXIS PHARM holds the US marketing authorisation.