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EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PHARMOBEDIENT · Approved 2018-04-09

Drug application

FDA Application #
ANDA206436
Application type
Abbreviated New Drug Application (Generic)
Brand name
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Generic name
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Active ingredients
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Sponsor
PHARMOBEDIENT
Manufacturer
Mylan Pharmaceuticals Inc.
First approval
2018-04-09

Source

Authoritative
Drugs@FDA application overview
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