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FDA ANDA · ANDA090894
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Sponsor: TEVA PHARMS USA
APPLICATION
ANDA090894
TYPE
ANDA
ORIGINAL APPROVAL
2017-06-08
LATEST ACTION
2024-07-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEPrescription
EMTRICITABINE 200MG, TENOFOVIR DISOPROXIL FUMARATE 300MG · TABLET · ORAL
Approval history
2024-07-11Labeling · Supplement 13 · standardAP
2022-03-31Labeling · Supplement 8 · standardAP
2022-03-31Labeling · Supplement 6 · standardAP
2019-07-01REMS · Supplement 4AP
2018-07-24REMS · Supplement 3AP
2017-12-08REMS · Supplement 2AP
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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