Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 203283
Company: MACLEODS PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE 300MG; 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
11/08/2012 ORIG-1 Tentative Approval Type 5 - New Formulation or New Manufacturer STANDARD Letter (PDF)

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https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203283Orig1s000TAltr.pdf

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