← FDA DRUG APPROVALS

FDA NDA · NDA200623

LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

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APPLICATION
NDA200623
TYPE
NDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATENone (Tentative Approval)
LAMIVUDINE 300MG, TENOFOVIR DISOPROXIL FUMARATE 300MG · TABLET · ORAL

Approval history

2011-03-04Type 4 - New Combination · Original · standardLetterTA
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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