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KETOTIFEN FUMARATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: UNICHEM · Approved 2020-06-01

Drug application

FDA Application #

ANDA204059

Application type

Abbreviated New Drug Application (Generic)

Brand name

KETOTIFEN FUMARATE

Generic name

KETOTIFEN FUMARATE

Active ingredients

KETOTIFEN FUMARATE

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

Marketing status

Over-the-counter

Sponsor

UNICHEM

Manufacturer

Unichem Pharmaceuticals (USA), Inc.

First approval

2020-06-01

Source

Authoritative

Drugs@FDA application overview

Machine

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