← FDA DRUG APPROVALS

FDA ANDA · ANDA203053

EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

Sponsor: HETERO LABS LTD V

APPLICATION
ANDA203053
TYPE
ANDA
ORIGINAL APPROVAL
2022-01-24
LATEST ACTION
2022-01-24
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

2022-01-24UNKNOWN · OriginalLetterAP
VIEW ON DRUGS@FDA ↗

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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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