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FDA ANDA · ANDA212689
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Sponsor: ZYDUS PHARMS
APPLICATION
ANDA212689
TYPE
ANDA
ORIGINAL APPROVAL
2020-02-28
LATEST ACTION
2024-12-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEPrescription
EMTRICITABINE 167MG, TENOFOVIR DISOPROXIL FUMARATE 250MG · TABLET · ORAL
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEPrescription
EMTRICITABINE 100MG, TENOFOVIR DISOPROXIL FUMARATE 150MG · TABLET · ORAL
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEPrescription
EMTRICITABINE 133MG, TENOFOVIR DISOPROXIL FUMARATE 200MG · TABLET · ORAL
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEPrescription
EMTRICITABINE 200MG, TENOFOVIR DISOPROXIL FUMARATE 300MG · TABLET · ORAL
Approval history
2024-12-04Labeling · Supplement 2 · standardAP
2024-12-04Labeling · Supplement 3 · standardAP
2021-07-01UNKNOWN · Original · standardAP
2021-03-08Labeling · Supplement 1 · standardAP
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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