Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077268
Company: AUROBINDO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZIDOVUDINE ZIDOVUDINE 50MG/5ML SYRUP;ORAL Prescription AA 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
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/2005/077268ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077268TA_ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
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.

ZIDOVUDINE

SYRUP;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 SYRUP;ORAL Prescription Yes AA 019910 VIIV HLTHCARE
ZIDOVUDINE ZIDOVUDINE 50MG/5ML SYRUP;ORAL Prescription No AA 077268 AUROBINDO
ZIDOVUDINE ZIDOVUDINE 50MG/5ML SYRUP;ORAL Prescription No AA 077981 CIPLA LTD

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