Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 070325
Company: MYLAN

Products on ANDA 070325

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIAZEPAM	DIAZEPAM	10MG	TABLET;ORAL	Prescription	AB	No	No
DIAZEPAM	DIAZEPAM	2MG	TABLET;ORAL	Prescription	AB	No	No
DIAZEPAM	DIAZEPAM	5MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070325

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/04/1985	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
04/11/2024	SUPPL-30	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/11/2024	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
04/11/2024	SUPPL-25	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
04/11/2024	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
11/25/2008	SUPPL-19	Labeling		Label is not available on this site.
12/19/2002	SUPPL-12	Labeling		Label is not available on this site.
02/25/1998	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
02/05/1998	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
09/30/1993	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
05/14/1993	SUPPL-7	Labeling		Label is not available on this site.
06/19/1989	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
12/29/1989	SUPPL-4	Labeling		Label is not available on this site.
02/03/1988	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
12/08/1986	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 070325

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
DIAZEPAM	DIAZEPAM	10MG	TABLET;ORAL	Prescription	No	AB	077749	STRIDES PHARMA
VALIUM	DIAZEPAM	10MG	TABLET;ORAL	Prescription	Yes	AB	013263	WAYLIS THERAP

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

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