← FDA DRUG APPROVALS

FDA NDA · NDA207315

LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE

Sponsor: HETERO LABS LTD III

APPLICATION
NDA207315
TYPE
NDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATENone (Tentative Approval)
LAMIVUDINE 75MG, TENOFOVIR DISOPROXIL FUMARATE 75MG · TABLET · ORAL

Approval history

2017-05-05Type 4 - New Combination · Original · standard — Letter ↗TA
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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