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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208775
Company: CIPLA LIMITED
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ABACAVIR AND LAMIVUDINE ABACAVIR; LAMIVUDINE 120MG;60MG TABLET, FOR SUSPENSION;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
04/06/2017 ORIG-1 Tentative Approval Type 3 - New Dosage Form STANDARD

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