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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070918
Company: HOSPIRA

Products on ANDA 070918

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NALBUPHINE HYDROCHLORIDE	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070918

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
12/15/2023	SUPPL-34	Labeling-Package Insert		Label is not available on this site.
12/01/2023	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
10/16/2019	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
12/16/2016	SUPPL-26	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/16/2016	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
11/30/2007	SUPPL-18	Labeling		Label is not available on this site.
10/25/2002	SUPPL-14	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
07/12/1999	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
05/05/1998	SUPPL-12	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
02/27/1997	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
02/27/1997	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
02/27/1997	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
10/03/1996	SUPPL-8	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 070918

NALBUPHINE HYDROCHLORIDE

INJECTABLE;INJECTION; 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	INJECTABLE;INJECTION	Prescription	No	AP	070916	HOSPIRA
NALBUPHINE HYDROCHLORIDE	NALBUPHINE HYDROCHLORIDE	20MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	070918	HOSPIRA

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