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FDA ANDA · ANDA206436
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Sponsor: PHARMOBEDIENT
APPLICATION
ANDA206436
TYPE
ANDA
ORIGINAL APPROVAL
2018-04-09
LATEST ACTION
2024-09-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEDiscontinued
EMTRICITABINE 200MG, TENOFOVIR DISOPROXIL FUMARATE 300MG · TABLET · ORAL
Approval history
2024-09-16Labeling · Supplement 7 · standardAP
2024-09-16Labeling · Supplement 8 · standardAP
2024-09-16Labeling · Supplement 4 · standardAP
2024-09-16Labeling · Supplement 2 · standardAP
2019-07-01REMS · Supplement 3AP
2018-07-24REMS · Supplement 1AP
2018-04-09UNKNOWN · 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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