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FDA NDA · NDA205861

EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

Sponsor: MACLEODS PHARMS LTD

APPLICATION
NDA205861
TYPE
NDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATENone (Tentative Approval)
EFAVIRENZ 600MG, LAMIVUDINE 300MG, TENOFOVIR DISOPROXIL FUMARATE 300MG · TABLET · ORAL

Approval history

2014-08-14Type 5 - New Formulation or New Manufacturer · 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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