ACUVUE Theravision with Ketotifen
These highlights do not include all the information needed to use ACUVUE® THERAVISION™ WITH KETOTIFEN safely and effectively. See full prescribing information for ACUVUE® THERAVISION™ WITH KETOTIFEN. ACUVUE THERAVISION™ WITH KETOTIFEN (etafilcon A drug-eluting contact lens with ketotifen), for ophthalmic use Initial U.S. Approval: 2022
Approved
Approval ID
d222d68c-911e-48a9-9bde-a1ca7e992d18
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 11, 2022
Manufacturers
FDA
Johnson & Johnson Vision Care, Inc.
DUNS: 004060273
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ketotifen fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60123-019
Application NumberNDA022388
Product Classification
M
Marketing Category
C73594
G
Generic Name
ketotifen fumarate
Product Specifications
Route of AdministrationINTRAOCULAR
Effective DateFebruary 28, 2022
FDA Product Classification
INGREDIENTS (6)
SODIUM BORATEInactive
Code: 91MBZ8H3QO
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
ketotifen fumarateActive
Quantity: 0.019 mg in 1 1
Code: HBD503WORO
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PENTETIC ACIDInactive
Code: 7A314HQM0I
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT