An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 217843
Company: AUROBINDO PHARMA LTD

Products on ANDA 217843

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217843

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/14/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217843

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

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

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

Top