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FDA NDA · NDA022388

ACUVUE THERAVISION WITH KETOTIFEN

Sponsor: JOHNSON JOHNSON VISN

APPLICATION
NDA022388
TYPE
NDA
ORIGINAL APPROVAL
2022-02-25
LATEST ACTION
2022-02-25
ROUTE
OPHTHALMIC
DOSAGE FORM
DRUG-ELUTING CONTACT LENS
MARKETING STATUS
Discontinued

Products

ACUVUE THERAVISION WITH KETOTIFEN · ReferenceDiscontinued
KETOTIFEN FUMARATE EQ 19MCG BASE · DRUG-ELUTING CONTACT LENS · OPHTHALMIC

Approval history

2022-02-25Type 3 - New Dosage Form and Type 4 - New Combination · Original · standardLabelAP
2022-02-25Type 3 - New Dosage Form · Supplement 1 · standardLetterAP
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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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