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BOSENTAN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS · Approved 2026-02-17

Drug application

FDA Application #

ANDA213981

Application type

Abbreviated New Drug Application (Generic)

Brand name

BOSENTAN

Generic name

BOSENTAN

Active ingredients

BOSENTAN

Dosage form

TABLET, FOR SUSPENSION

Route

ORAL

Marketing status

Prescription

Sponsor

ZYDUS PHARMS

Manufacturer

Zydus Pharmaceuticals USA Inc.

First approval

2026-02-17

Source

Authoritative

Drugs@FDA application overview

Machine

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