APPLICATION
ANDA077200
TYPE
ANDA
ORIGINAL APPROVAL
2008-09-02
LATEST ACTION
2015-09-16
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Over-the-counter
Products
ZADITOROver-the-counter
KETOTIFEN FUMARATE EQ 0.025% BASE · SOLUTION/DROPS · OPHTHALMIC
Approval history
2015-09-16Labeling · Supplement 2 · standardAP
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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