Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 200793
Company: MATRIX LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LAMIVUDINE/NEVIRAPINE/ZIDOVUDINE TABLETS Lamivudine; Nevirapine; Zidovudine 30MG; 50MG; 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
07/08/2010 ORIG-1 Tentative Approval Type 3 - New Dosage Form and Type 4 - New Combination PRIORITY Letter (PDF)

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https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200793s000ltr.pdf

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