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COMPLERA

NDA · New Drug Application · Sponsor: GILEAD SCIENCES INC · Approved 2011-08-10

Drug application

FDA Application #
NDA202123
Application type
New Drug Application
Brand name
COMPLERA
Generic name
EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE
Active ingredients
EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Sponsor
GILEAD SCIENCES INC
Manufacturer
Gilead Sciences, Inc.
First approval
2011-08-10

Source

Authoritative
Drugs@FDA application overview
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