← FDA DRUG APPROVALS

FDA NDA · NDA204505

LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE

Sponsor: AUROBINDO PHARMA LTD

APPLICATION
NDA204505
TYPE
NDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINENone (Tentative Approval)
LAMIVUDINE 300MG, TENOFOVIR DISOPROXIL FUMARATE 300MG, NEVIRAPINE 200MG · TABLET · ORAL

Approval history

2013-10-18Type 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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