Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070916
Company: HOSPIRA

Products on ANDA 070916

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070916

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/03/1989	ORIG-1	Approval				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-28	Labeling-Package Insert		Label is not available on this site.
08/27/2024	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
12/01/2023	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
10/16/2019	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
12/16/2016	SUPPL-18	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/16/2016	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
11/30/2007	SUPPL-12	Labeling		Label is not available on this site.
07/12/1999	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
01/24/1997	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
01/24/1997	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
10/03/1996	SUPPL-7	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
04/26/1996	SUPPL-5	Labeling		Label is not available on this site.
02/28/1991	SUPPL-3	Labeling		Label is not available on this site.
07/25/1990	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 070916

NALBUPHINE HYDROCHLORIDE

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