Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071136
Company: DR REDDYS LABS SA

Products on ANDA 071136

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIAZEPAM	DIAZEPAM	10MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071136

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-39	Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
08/02/2021	SUPPL-36	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
03/09/2015	SUPPL-32	Labeling-Package Insert		Label is not available on this site.
08/06/2008	SUPPL-25	Labeling		Label is not available on this site.
04/25/2001	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
06/21/2001	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
10/17/1997	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
07/02/1993	SUPPL-11	Labeling		Label is not available on this site.
01/28/1991	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
05/31/1991	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
06/29/1990	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
07/18/1988	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
07/18/1988	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
07/18/1988	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 071136

DIAZEPAM

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIAZEPAM	DIAZEPAM	10MG	TABLET;ORAL	Prescription	No	AB	217843	AUROBINDO PHARMA LTD
DIAZEPAM	DIAZEPAM	10MG	TABLET;ORAL	Prescription	No	AB	071136	DR REDDYS LABS SA
DIAZEPAM	DIAZEPAM	10MG	TABLET;ORAL	Prescription	No	AB	071322	IVAX SUB TEVA PHARMS
DIAZEPAM	DIAZEPAM	10MG	TABLET;ORAL	Prescription	No	AB	070325	MYLAN
DIAZEPAM	DIAZEPAM	10MG	TABLET;ORAL	Prescription	No	AB	070464	NUVO PHARM
VALIUM	DIAZEPAM	10MG	TABLET;ORAL	Prescription	Yes	AB	013263	WAYLIS THERAP