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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077268
Company: AUROBINDO

Products on ANDA 077268

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZIDOVUDINE	ZIDOVUDINE	50MG/5ML	SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077268

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/19/2005	ORIG-1	Approval			Letter (PDF) Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077268TA_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077268ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/09/2020	SUPPL-19	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
06/11/2020	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
06/11/2020	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
06/11/2020	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
06/11/2020	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
12/11/2015	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
10/30/2012	SUPPL-8	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
03/06/2012	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
12/30/2011	SUPPL-6	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 077268

ZIDOVUDINE

SOLUTION;ORAL; 50MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RETROVIR	ZIDOVUDINE	50MG/5ML	SOLUTION;ORAL	Prescription	Yes	AA	019910	VIIV HLTHCARE
ZIDOVUDINE	ZIDOVUDINE	50MG/5ML	SOLUTION;ORAL	Prescription	No	AA	077268	AUROBINDO
ZIDOVUDINE	ZIDOVUDINE	50MG/5ML	SOLUTION;ORAL	Prescription	No	AA	077981	CIPLA LTD

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