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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216050
Company: SOMERSET THERAPS LLC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NALBUPHINE HYDROCHLORIDE NALBUPHINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Prescription AP No No
NALBUPHINE HYDROCHLORIDE NALBUPHINE HYDROCHLORIDE 20MG/ML (20MG/ML) SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Prescription AP No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/19/2024 ORIG-1 Approval STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/22/2025 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

NALBUPHINE HYDROCHLORIDE

SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS; 10MG/ML (10MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NALBUPHINE HYDROCHLORIDE NALBUPHINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Prescription No AP 070914 HOSPIRA
NALBUPHINE HYDROCHLORIDE NALBUPHINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Prescription No AP 216050 SOMERSET THERAPS LLC

SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS; 20MG/ML (20MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NALBUPHINE HYDROCHLORIDE NALBUPHINE HYDROCHLORIDE 20MG/ML (20MG/ML) SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Prescription No AP 070916 HOSPIRA
NALBUPHINE HYDROCHLORIDE NALBUPHINE HYDROCHLORIDE 20MG/ML (20MG/ML) SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Prescription No AP 216050 SOMERSET THERAPS LLC
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