← FDA DRUG APPROVALS

FDA ANDA · ANDA204287

EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

Sponsor: MACLEODS PHARMS LTD

APPLICATION
ANDA204287
TYPE
ANDA
ORIGINAL APPROVAL
2021-09-13
LATEST ACTION
2021-09-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATEPrescription
EFAVIRENZ 600MG, EMTRICITABINE 200MG, TENOFOVIR DISOPROXIL FUMARATE 300MG · TABLET · ORAL

Approval history

2021-09-13UNKNOWN · Original — Letter ↗AP
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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