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FDA ANDA · ANDA212114
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Sponsor: LAURUS
APPLICATION
ANDA212114
TYPE
ANDA
ORIGINAL APPROVAL
2019-07-26
LATEST ACTION
2025-07-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEPrescription
EMTRICITABINE 200MG, TENOFOVIR DISOPROXIL FUMARATE 300MG · TABLET · ORAL
Approval history
2025-07-18Labeling · Supplement 10 · standardAP
2025-07-18Labeling · Supplement 6 · standardAP
2025-07-18Labeling · Supplement 19 · standardAP
2025-07-18Labeling · Supplement 17 · standardAP
2025-07-18Labeling · Supplement 9 · standardAP
2019-07-26UNKNOWN · Original · 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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