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Active ingredient

Ketotifen

23 finished FDA listings contain Ketotifen as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
KETOTIFEN FUMARATE
Dosage forms
Solution, Solution/ Drops
Routes
Ophthalmic
Manufacturers / labelers
21
Strengths listed
.25 mg/ml · .35 mg/ml
Brand names in FDA listings
Alaway, Equate Eye Itch Relief, Eye Itch Releif, Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution, Zaditor

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 6146

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 021996BAUSCH AND LOMB2006-12-0115
ANDA 077958SENTISS2007-07-265
ANDA 077200ALCON PHARMS LTD2008-09-021
ANDA 204059UNICHEM2020-06-012

Official labeling on DailyMed

Showing the 12 most recent of 23 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.