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FDA ANDA · ANDA077958

KETOTIFEN FUMARATE OPHTHALMIC SOLUTION

ketotifen fumarate

Sponsor: SENTISS

APPLICATION
ANDA077958
TYPE
ANDA
ORIGINAL APPROVAL
2007-07-26
LATEST ACTION
2014-02-19
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Over-the-counter

Products

KETOTIFEN FUMARATEOver-the-counter
KETOTIFEN FUMARATE EQ 0.025% BASE · SOLUTION/DROPS · OPHTHALMIC

Approval history

2014-02-19Manufacturing (CMC) · Supplement 11AP
2007-07-26OriginalAP
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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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