Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071321
Company: IVAX SUB TEVA PHARMS

Products on ANDA 071321

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIAZEPAM	DIAZEPAM	5MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071321

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/10/1986	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
03/09/2015	SUPPL-33	Labeling-Package Insert		Label is not available on this site.
01/28/2013	SUPPL-31	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
07/23/2008	SUPPL-26	Labeling		Label is not available on this site.
07/29/2002	SUPPL-13	Manufacturing (CMC)-Facility		Label is not available on this site.
03/12/2002	SUPPL-12	Manufacturing (CMC)-Facility		Label is not available on this site.
03/27/2002	SUPPL-11	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/28/2000	SUPPL-10	Manufacturing (CMC)-Facility		Label is not available on this site.
03/30/1998	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
10/29/1996	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
10/30/1996	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
10/22/1993	SUPPL-6	Labeling		Label is not available on this site.
07/25/1991	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
03/14/1990	SUPPL-4	Labeling		Label is not available on this site.
03/14/1990	SUPPL-3	Labeling		Label is not available on this site.
03/25/1987	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
03/25/1987	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 071321

DIAZEPAM

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIAZEPAM	DIAZEPAM	5MG	TABLET;ORAL	Prescription	No	AB	217843	AUROBINDO PHARMA LTD
DIAZEPAM	DIAZEPAM	5MG	TABLET;ORAL	Prescription	No	AB	071135	DR REDDYS LABS SA
DIAZEPAM	DIAZEPAM	5MG	TABLET;ORAL	Prescription	No	AB	071321	IVAX SUB TEVA PHARMS
DIAZEPAM	DIAZEPAM	5MG	TABLET;ORAL	Prescription	No	AB	070325	MYLAN
DIAZEPAM	DIAZEPAM	5MG	TABLET;ORAL	Prescription	No	AB	077749	STRIDES PHARMA
VALIUM	DIAZEPAM	5MG	TABLET;ORAL	Prescription	Yes	AB	013263	WAYLIS THERAP