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EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HETERO LABS LTD III · Approved 2021-10-07

Drug application

FDA Application #

ANDA201806

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

HETERO LABS LTD III

Manufacturer

Camber Pharmaceuticals, Inc.

First approval

2021-10-07

Source

Authoritative

Drugs@FDA application overview

Machine

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