Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077267
Company: AUROBINDO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZIDOVUDINE ZIDOVUDINE 300MG TABLET;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
09/19/2005 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077267ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/26/2015 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

10/30/2012 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

02/28/2012 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

08/24/2010 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

05/19/2011 SUPPL-10 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

06/14/2010 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

05/08/2009 SUPPL-8 Labeling

Label is not available on this site.

06/09/2008 SUPPL-6 Labeling

Label is not available on this site.

06/19/2007 SUPPL-3 Labeling

Label is not available on this site.

ZIDOVUDINE

TABLET;ORAL; 300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ZIDOVUDINE ZIDOVUDINE 300MG TABLET;ORAL Prescription No AB 077267 AUROBINDO
ZIDOVUDINE ZIDOVUDINE 300MG TABLET;ORAL Prescription No AB 090561 CIPLA
ZIDOVUDINE ZIDOVUDINE 300MG TABLET;ORAL Prescription No AB 090092 HETERO LABS LTD III
ZIDOVUDINE ZIDOVUDINE 300MG TABLET;ORAL Prescription No AB 078922 MYLAN PHARMS INC
ZIDOVUDINE ZIDOVUDINE 300MG TABLET;ORAL Prescription No AB 076844 WEST-WARD PHARMS INT

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