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FDA ANDA · ANDA209721
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Sponsor: AMNEAL PHARMS CO
APPLICATION
ANDA209721
TYPE
ANDA
ORIGINAL APPROVAL
2018-08-22
LATEST ACTION
2019-07-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEPrescription
EMTRICITABINE 100MG, TENOFOVIR DISOPROXIL FUMARATE 150MG · TABLET · ORAL
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEPrescription
EMTRICITABINE 200MG, TENOFOVIR DISOPROXIL FUMARATE 300MG · TABLET · ORAL
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEPrescription
EMTRICITABINE 133MG, TENOFOVIR DISOPROXIL FUMARATE 200MG · TABLET · ORAL
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEPrescription
EMTRICITABINE 167MG, TENOFOVIR DISOPROXIL FUMARATE 250MG · TABLET · ORAL
Approval history
2019-07-01REMS · Supplement 1AP
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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