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FDA Approval

ACUVUE Theravision with Ketotifen

CompanyJohnson & Johnson Vision Care, Inc. (DUNS: 004060273)

Effective Date

March 11, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Ketotifen(0.019 mg in 1 1)

Manufacturing Establishments (3)

Johnson & Johnson Vision Care Ireland UC

Labeler

Johnson & Johnson Vision Care, Inc.

DUNS Number

986063418

Labeler

Johnson & Johnson Vision Care, Inc.

DUNS Number

437723684

Ortec

Labeler

Johnson & Johnson Vision Care, Inc.

DUNS Number

025094859

Products (1)

ACUVUE Theravision with Ketotifen

NDC Product Code

60123-019

Application Number

NDA022388

Marketing Category

NDA (C73594)

Route of Administration

INTRAOCULAR

Effective Date

February 28, 2022

Ingredients

SODIUM BORATEInactive

Code: 91MBZ8H3QOClass: IACT

BORIC ACIDInactive

Code: R57ZHV85D4Class: IACT

KetotifenActive

Code: HBD503WOROClass: ACTIMQuantity: 0.019 mg in 1 1

WATERInactive

Code: 059QF0KO0RClass: IACT

PENTETIC ACIDInactive

Code: 7A314HQM0IClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

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