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EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MACLEODS PHARMS LTD · Approved 2026-04-07

Drug application

FDA Application #
ANDA214216
Application type
Abbreviated New Drug Application (Generic)
Brand name
EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE
Generic name
Emtricitabine
Active ingredients
EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Sponsor
MACLEODS PHARMS LTD
First approval
2026-04-07

Source

Authoritative
Drugs@FDA application overview
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