Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021988
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets LAMIVUDINE; ZIDOVUDINE; NEVIRAPINE 150MG; 300MG; 200MG 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
03/02/2007 ORIG-1 Tentative Approval Type 4 - New Combination PRIORITY Letter (PDF)

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