Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078349
Company: CIPLA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZIDOVUDINE ZIDOVUDINE 100MG CAPSULE;ORAL Prescription AB No No
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.

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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