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): 078128
Company: AUROBINDO PHARMA LTD

Products on ANDA 078128

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZIDOVUDINE	ZIDOVUDINE	100MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078128

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/27/2006	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/078128ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/08/2020	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
04/08/2020	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
04/08/2020	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
04/08/2020	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
06/26/2015	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
08/01/2012	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
08/01/2012	SUPPL-8	Labeling-Package Insert, Labeling-Package Insert		Label is not available on this site.
11/04/2010	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
06/14/2010	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
05/13/2009	SUPPL-3	Labeling		Label is not available on this site.
06/09/2008	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 078128

ZIDOVUDINE

CAPSULE;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RETROVIR	ZIDOVUDINE	100MG	CAPSULE;ORAL	Prescription	Yes	AB	019655	VIIV HLTHCARE
ZIDOVUDINE	ZIDOVUDINE	100MG	CAPSULE;ORAL	Prescription	No	AB	078128	AUROBINDO PHARMA LTD
ZIDOVUDINE	ZIDOVUDINE	100MG	CAPSULE;ORAL	Prescription	No	AB	078349	CIPLA LTD

Top