General MedicationsINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSStandard

NALBUPHINE HYDROCHLORIDE

Standard Dose

10MG/ML (10MG/ML)

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview NALBUPHINE HYDROCHLORIDE is listed in Drugs@FDA under application 216050 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient NALBUPHINE HYDROCHLORIDE Form and strength SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS - 10MG/ML (10MG/ML) Sponsor SOMERSET THERAPS LLC Submission history Latest submission status date: 2025-12-22 00:00:00.

Structured Monograph

Clinical summary

Approval overview NALBUPHINE HYDROCHLORIDE is listed in Drugs@FDA under application 216050 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient NALBUPHINE HYDROCHLORIDE Form and strength SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS - 10MG/ML (10MG/ML) Sponsor SOMERSET THERAPS LLC Submission history Latest submission status date: 2025-12-22 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.