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EMTRICITABINE AND TENOFOVIR ALAFENAMIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: CIPLA LIMITED · Approved 2025-10-10

Drug application

FDA Application #
ANDA211680
Application type
Abbreviated New Drug Application (Generic)
Brand name
EMTRICITABINE AND TENOFOVIR ALAFENAMIDE
Generic name
Emtricitabine, Tenofovir Alafenamide
Active ingredients
EMTRICITABINE, TENOFOVIR ALAFENAMIDE
Dosage form
TABLET
Route
—
Marketing status
None (Tentative Approval)
Sponsor
CIPLA LIMITED
First approval
2025-10-10

Source

Authoritative
Drugs@FDA application overview
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