Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071134
Company: DR REDDYS LABS SA

Products on ANDA 071134

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIAZEPAM	DIAZEPAM	2MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071134

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/03/1987	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
08/02/2021	SUPPL-35	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/02/2021	SUPPL-32	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/09/2015	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
08/06/2008	SUPPL-21	Labeling		Label is not available on this site.
04/25/2001	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
06/21/2001	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
07/02/1993	SUPPL-10	Labeling		Label is not available on this site.
01/28/1991	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
05/31/1991	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
09/07/1988	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
09/07/1988	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
05/04/1988	SUPPL-4	Labeling		Label is not available on this site.
08/11/1988	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 071134

DIAZEPAM

TABLET;ORAL; 2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIAZEPAM	DIAZEPAM	2MG	TABLET;ORAL	Prescription	No	AB	217843	AUROBINDO PHARMA LTD
DIAZEPAM	DIAZEPAM	2MG	TABLET;ORAL	Prescription	No	AB	071134	DR REDDYS LABS SA
DIAZEPAM	DIAZEPAM	2MG	TABLET;ORAL	Prescription	No	AB	071307	IVAX SUB TEVA PHARMS
DIAZEPAM	DIAZEPAM	2MG	TABLET;ORAL	Prescription	No	AB	070325	MYLAN
DIAZEPAM	DIAZEPAM	2MG	TABLET;ORAL	Prescription	No	AB	077749	STRIDES PHARMA
VALIUM	DIAZEPAM	2MG	TABLET;ORAL	Prescription	Yes	AB	013263	WAYLIS THERAP