Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071174
Company: SUN PHARM INDUSTRIES

Products on ANDA 071174

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TEMAZEPAM	TEMAZEPAM	15MG	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071174

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/10/1986	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
05/26/2021	SUPPL-26	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/12/2019	SUPPL-25	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/12/2019	SUPPL-24	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/04/2011	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
09/14/2009	SUPPL-20	Labeling		Label is not available on this site.
12/01/1998	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
12/23/1994	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
10/05/1993	SUPPL-12	Labeling		Label is not available on this site.
04/03/1992	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
04/03/1992	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
03/01/1991	SUPPL-8	Labeling		Label is not available on this site.
05/31/1990	SUPPL-7	Bioequivalence		Label is not available on this site.
01/27/1989	SUPPL-4	Labeling		Label is not available on this site.
04/01/1987	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.