← FDA DRUG APPROVALS

FDA ANDA · ANDA203041

EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

Sponsor: AUROBINDO PHARMA

APPLICATION
ANDA203041
TYPE
ANDA
ORIGINAL APPROVAL
2018-09-04
LATEST ACTION
2020-01-27
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

2020-01-27Labeling · Supplement 8 · standardAP
2018-09-04UNKNOWN · Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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