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FDA NDA · NDA021996

EYE ITCH RELIEF

ketotifen fumarate

Sponsor: BAUSCH AND LOMB

APPLICATION
NDA021996
TYPE
NDA
ORIGINAL APPROVAL
2006-12-01
LATEST ACTION
2021-04-14
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Over-the-counter

Products

CHILDREN'S ALAWAY · ReferenceOver-the-counter
KETOTIFEN FUMARATE EQ 0.025% BASE · SOLUTION/DROPS · OPHTHALMIC
ALAWAY · ReferenceOver-the-counter
KETOTIFEN FUMARATE EQ 0.025% BASE · SOLUTION/DROPS · OPHTHALMIC

Approval history

2021-04-14Labeling · Supplement 17 · standard — Letter ↗AP
2015-02-11Labeling · Supplement 8 · standard — Letter ↗AP
2015-02-11Manufacturing (CMC) · Supplement 5 · standardAP
2007-04-18Manufacturing (CMC) · Supplement 1 — Label ↗AP
2006-12-01Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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