COMBIGAN
These highlights do not include all the information needed to use COMBIGAN safely and effectively. See full prescribing information for COMBIGAN. COMBIGAN (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% Initial U.S. Approval: 2007
Approved
Approval ID
8c641b6c-3335-4ec3-89b9-2d97a8901062
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 15, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-6295
Application NumberNDA021398
Product Classification
M
Marketing Category
C73594
G
Generic Name
brimonidine tartrate, timolol maleate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateSeptember 2, 2011
FDA Product Classification
INGREDIENTS (8)
benzalkonium chlorideInactive
Code: F5UM2KM3W7
Classification: IACT
sodium phosphate, monobasicInactive
Code: 3980JIH2SW
Classification: IACT
brimonidine tartrateActive
Quantity: 2 mg in 1 mL
Code: 4S9CL2DY2H
Classification: ACTIB
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
timolol maleateActive
Quantity: 5 mg in 1 mL
Code: P8Y54F701R
Classification: ACTIB
sodium phosphate, dibasicInactive
Code: GR686LBA74
Classification: IACT