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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071583
Company: HOSPIRA

Products on ANDA 071583

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIAZEPAM	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071583

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/13/1987	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
04/25/2023	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
02/05/2021	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
02/21/2019	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
12/16/2016	SUPPL-21	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/06/2015	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
04/30/1999	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
01/06/1994	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
06/23/1993	SUPPL-4	Labeling		Label is not available on this site.
04/03/1990	SUPPL-3	Labeling		Label is not available on this site.
03/09/1990	SUPPL-2	Labeling		Label is not available on this site.
03/16/1989	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 071583

DIAZEPAM

INJECTABLE;INJECTION; 50MG/10ML (5MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIAZEPAM	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	211998	BELOTECA
DIAZEPAM	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	070311	HIKMA
DIAZEPAM	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	071583	HOSPIRA

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