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General MedicationsINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSGeneric

NUBAIN

NALBUPHINE HYDROCHLORIDE

Standard Dose
20MG/ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview NUBAIN is listed in Drugs@FDA under application 018024 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient NALBUPHINE HYDROCHLORIDE Form and strength SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS - 20MG/ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor PH HEALTH Submission history Latest submission status date: 2025-12-22 00:00:00.

Structured Monograph

Clinical summary

Approval overview NUBAIN is listed in Drugs@FDA under application 018024 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient NALBUPHINE HYDROCHLORIDE Form and strength SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS - 20MG/ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor PH HEALTH Submission history Latest submission status date: 2025-12-22 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.
NUBAIN (NALBUPHINE HYDROCHLORIDE) | Drug Monograph | MedicHelpline