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BEPOTASTINE BESILATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SANDOZ INC · Approved 2017-06-07

Drug application

FDA Application #

ANDA206080

Application type

Abbreviated New Drug Application (Generic)

Brand name

BEPOTASTINE BESILATE

Generic name

Bepotastine Besilate

Active ingredients

BEPOTASTINE BESILATE

Dosage form

SOLUTION

Route

OPHTHALMIC

Marketing status

None (Tentative Approval)

Sponsor

SANDOZ INC

First approval

2017-06-07

Source

Authoritative

Drugs@FDA application overview

Machine

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