BRIMONIDINE TARTRATE and TIMOLOL MALEATE
These highlights do not include all the information needed to use BRIMONIDINE TARTRATE and TIMOLOL MALEATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for BRIMONIDINE TARTRATE and TIMOLOL MALEATE OPHTHALMIC SOLUTION. BRIMONIDINE TARTRATE and TIMOLOL MALEATE Ophthalmic solution 0.2%/0.5% For topical administration Initial U.S. Approval: 2007
Approved
Approval ID
8b13bd5a-b65f-4e39-83f1-8d3abe97d4c0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 24, 2022
Manufacturers
FDA
Pacific Pharma, Inc.
DUNS: 877645267
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
BRIMONIDINE TARTRATE, TIMOLOL MALEATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82182-455
Application NumberNDA021398
Product Classification
M
Marketing Category
C73605
G
Generic Name
BRIMONIDINE TARTRATE, TIMOLOL MALEATE
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 15, 2023
FDA Product Classification
INGREDIENTS (8)
BRIMONIDINE TARTRATEActive
Quantity: 2 mg in 1 mL
Code: 4S9CL2DY2H
Classification: ACTIB
TIMOLOL MALEATEActive
Quantity: 5 mg in 1 mL
Code: P8Y54F701R
Classification: ACTIM
SODIUM PHOSPHATEInactive
Code: SE337SVY37
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM PHOSPHATE, MONOBASICInactive
Code: 3980JIH2SW
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT