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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090561
Company: CIPLA
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
10/27/2010 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090561s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/07/2020 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

02/07/2020 SUPPL-12 Labeling-Patient Package Insert

Label is not available on this site.

02/07/2020 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

02/07/2020 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

02/07/2020 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

10/25/2012 SUPPL-5 Labeling-Package Insert

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
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