Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 205508
Company: EMCURE PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATAZANAVIR SULFATE; RITONAVIR ATAZANAVIR SULFATE; RITONAVIR 300MG; 100MG 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
03/17/2014 ORIG-1 Tentative Approval Type 4 - New Combination PRIORITY Letter (PDF)

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https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205508Orig1s000TAltr.pdf

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