Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090092
Company: HETERO LABS LTD III
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZIDOVUDINE ZIDOVUDINE 300MG TABLET;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/25/2008 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/090092s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/25/2010 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

03/05/2009 SUPPL-1 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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