Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077981
Company: CIPLA LTD
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
06/26/2008 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077981s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/08/2019 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

01/08/2019 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

01/08/2019 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

06/13/2017 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

06/13/2017 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

06/30/2015 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

06/30/2015 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

06/30/2015 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

05/31/2014 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

11/21/2013 SUPPL-17 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

11/21/2013 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

07/31/2013 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

08/09/2012 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

08/09/2012 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

01/10/2011 SUPPL-3 Labeling-Package Insert

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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