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EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: TEVA PHARMS USA · Approved 2018-11-09

Drug application

FDA Application #
ANDA091215
Application type
Abbreviated New Drug Application (Generic)
Brand name
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE
Generic name
EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Active ingredients
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Sponsor
TEVA PHARMS USA
Manufacturer
Teva Pharmaceuticals USA, Inc.
First approval
2018-11-09

Source

Authoritative
Drugs@FDA application overview
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