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BEPOTASTINE BESILATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SOMERSET THERAPS LLC · Approved 2024-08-14

Drug application

FDA Application #

ANDA217770

Application type

Abbreviated New Drug Application (Generic)

Brand name

BEPOTASTINE BESILATE

Generic name

BEPOTASTINE BESILATE

Active ingredients

BEPOTASTINE BESILATE

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

Marketing status

Prescription

Sponsor

SOMERSET THERAPS LLC

Manufacturer

Somerset Therapeutics, LLC

First approval

2024-08-14

Source

Authoritative

Drugs@FDA application overview

Machine

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