Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 206288
Company: CIPLA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DARUNAVIR DARUNAVIR 75MG TABLET;ORAL None (Tentative Approval) None No No
DARUNAVIR DARUNAVIR 150MG TABLET;ORAL None (Tentative Approval) None No No
DARUNAVIR DARUNAVIR 400MG TABLET;ORAL None (Tentative Approval) None No No
DARUNAVIR DARUNAVIR 600MG TABLET;ORAL None (Tentative Approval) None No No
DARUNAVIR DARUNAVIR 800MG 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
12/13/2017 ORIG-1 Tentative Approval STANDARD Letter (PDF)

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https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206288Orig1s000TAltr.pdf

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