Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 200406
Company: MICRO LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LAMIVUDINE LAMIVUDINE 150MG TABLET; ORAL None (Tentative Approval) None No No
LAMIVUDINE LAMIVUDINE 300MG 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
05/30/2012 ORIG-1 Tentative Approval

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