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FDA ANDA · ANDA090958
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Sponsor: CIPLA
APPLICATION
ANDA090958
TYPE
ANDA
ORIGINAL APPROVAL
2021-04-02
LATEST ACTION
2025-06-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEDiscontinued
EMTRICITABINE 200MG, TENOFOVIR DISOPROXIL FUMARATE 300MG · TABLET · ORAL
Approval history
2025-06-12Labeling · Supplement 9 · standardAP
2025-06-12Labeling · Supplement 10 · standardAP
2025-06-12Labeling · Supplement 4 · 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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