Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 206041
Company: MYLAN LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATAZANAVIR SULFATE;RITONAVIR;LAMIVUDINE;ZIDOVUDINE ATAZANAVIR SULFATE;RITONAVIR;LAMIVUDINE;ZIDOVUDINE 300MG;100MG;150MG;300MG TABLET;ORAL None (Tentative Approval) None 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
09/04/2014 ORIG-1 Tentative Approval Type 4 - New Combination STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206041Orig1s000TAltr.pdf

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