FDA — authorised 2 July 1986
- Application: ANDA070752
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: NALBUPHINE
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Status: approved
🇺🇸 NALBUPHINE in United States
FDA authorised NALBUPHINE on 2 July 1986 · 380 US adverse-event reports
Marketing authorisations
FDA — authorised 2 July 1986
- Application: ANDA070751
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: NALBUPHINE
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA — authorised 3 February 1989
- Application: ANDA070915
- Marketing authorisation holder: HOSPIRA
- Status: approved
FDA — authorised 27 February 1997
- Application: ANDA070918
- Marketing authorisation holder: HOSPIRA
- Indication: Manufacturing (CMC)
- 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: ANDA216050
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Status: approved
FDA
- Application: ANDA070692
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: NALBUPHINE
- Indication: Injectable — Injection
- Status: approved
FDA
- Application: ANDA070693
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: NALBUPHINE
- Indication: Injectable — Injection
- 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: 20 April 2025 – 20 April 2026
- Total reports: 380
Most-reported reactions
- Drug Hypersensitivity — 69 reports (18.16%)
- Off Label Use — 51 reports (13.42%)
- Pyrexia — 43 reports (11.32%)
- Drug Ineffective — 37 reports (9.74%)
- Febrile Bone Marrow Aplasia — 33 reports (8.68%)
- Hypotension — 32 reports (8.42%)
- Headache — 30 reports (7.89%)
- Pain — 29 reports (7.63%)
- Drug Interaction — 28 reports (7.37%)
- Vomiting — 28 reports (7.37%)
NALBUPHINE 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 approved in United States?
Yes. FDA authorised it on 2 July 1986; FDA authorised it on 2 July 1986; FDA authorised it on 3 February 1989.
Who is the marketing authorisation holder for NALBUPHINE in United States?
ABRAXIS PHARM holds the US marketing authorisation.