Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077981
Company: CIPLA LTD

Products on ANDA 077981

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 077981

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/26/2008	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077981s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/08/2019	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
01/08/2019	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
01/08/2019	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
06/13/2017	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
06/13/2017	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
06/30/2015	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
06/30/2015	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
06/30/2015	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
05/31/2014	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
11/21/2013	SUPPL-17	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
11/21/2013	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
07/31/2013	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
08/09/2012	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
08/09/2012	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
01/10/2011	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077981

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