Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078128
Company: AUROBINDO PHARMA 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
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
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.

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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