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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078349
Company: CIPLA LTD

Products on ANDA 078349

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 078349

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/23/2007	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078349s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/04/2019	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
01/04/2019	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
06/28/2017	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
06/28/2017	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
11/19/2015	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
08/08/2012	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
01/20/2012	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
10/31/2011	SUPPL-11	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
05/04/2011	SUPPL-8	Labeling-Container/Carton Labels		Label is not available on this site.
03/27/2009	SUPPL-5	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 078349

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

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