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BOSENTAN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NATCO PHARMA LTD · Approved 2025-02-05

Drug application

FDA Application #

ANDA213154

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

NATCO PHARMA LTD

Manufacturer

Lupin Pharmaceuticals, Inc.

First approval

2025-02-05

Source

Authoritative

Drugs@FDA application overview

Machine

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