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FDA ANDA · ANDA077354

KETOTIFEN FUMARATE

Sponsor: APOTEX INC

APPLICATION
ANDA077354
TYPE
ANDA
ORIGINAL APPROVAL
2006-05-09
LATEST ACTION
2007-08-22
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued

Products

KETOTIFEN FUMARATEDiscontinued
KETOTIFEN FUMARATE EQ 0.025% BASE · SOLUTION/DROPS · OPHTHALMIC

Approval history

2007-08-22Labeling · Supplement 5AP
2006-05-09OriginalAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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