Brimonidine tartrate and Timolol maleate
These highlights do not include all the information needed to use BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION. BRIMONIDINE TARTRATE and TIMOLOL MALEATE ophthalmic solution, for topical administration Initial U.S. Approval: 2007
Approved
Approval ID
7011a203-46cf-434d-ba11-253f107ff80f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2023
Manufacturers
FDA
Florida Pharmaceutical Products, LLC
DUNS: 084014259
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Brimonidine tartrate and Timolol maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71921-188
Application NumberANDA201949
Product Classification
M
Marketing Category
C73584
G
Generic Name
Brimonidine tartrate and Timolol maleate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateOctober 31, 2023
FDA Product Classification
INGREDIENTS (7)
SODIUM PHOSPHATEInactive
Code: SE337SVY37
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
TIMOLOL MALEATEActive
Quantity: 5 mg in 1 mL
Code: P8Y54F701R
Classification: ACTIM
BRIMONIDINE TARTRATEActive
Quantity: 2 mg in 1 mL
Code: 4S9CL2DY2H
Classification: ACTIM