Timolol Maleate
These highlights do not include all the information needed to use TIMOLOL MALEATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for TIMOLOL MALEATE OPHTHALMIC SOLUTION. TIMOLOL MALEATE ophthalmic solution, for topical ophthalmic use Initial U.S. Approval: 1978
Approved
Approval ID
b686bbad-1ef7-4b94-a316-4d182a40b89a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2024
Manufacturers
FDA
Bausch & Lomb Americas Inc.
DUNS: 118287629
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Timolol Maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82260-045
Application NumberNDA021516
Product Classification
M
Marketing Category
C73605
G
Generic Name
Timolol Maleate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJanuary 18, 2024
FDA Product Classification
INGREDIENTS (7)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RN
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Quantity: 0.05 mg in 1 mL
Code: F5UM2KM3W7
Classification: IACT
TIMOLOL MALEATEActive
Quantity: 5 mg in 1 mL
Code: P8Y54F701R
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT