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EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MACLEODS PHARMS LTD · Approved 2020-05-15

Drug application

FDA Application #
ANDA203442
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
MACLEODS PHARMS LTD
Manufacturer
Macleods Pharmaceuticals Limited
First approval
2020-05-15

Source

Authoritative
Drugs@FDA application overview
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