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FIDAXOMICIN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ACTAVIS LABS FL · Approved 2024-01-16

Drug application

FDA Application #

ANDA208443

Application type

Abbreviated New Drug Application (Generic)

Brand name

FIDAXOMICIN

Generic name

FIDAXOMICIN

Active ingredients

FIDAXOMICIN

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

ACTAVIS LABS FL

Manufacturer

Teva Pharmaceuticals, Inc.

First approval

2024-01-16

Source

Authoritative

Drugs@FDA application overview

Machine

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