Bromday
These highlights do not include all the information needed to use Bromday™ (bromfenac ophthalmic solution) 0.09% safely and effectively. See full prescribing information for Bromday. Bromday (bromfenac ophthalmic solution) 0.09% Initial U.S. Approval: 1997
Approved
Approval ID
5e9aae21-ca78-44a0-95be-67f83e55549b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 14, 2010
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.
bromfenac
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6301
Application NumberNDA021664
Product Classification
M
Marketing Category
C73594
G
Generic Name
bromfenac
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateOctober 3, 2011
FDA Product Classification
INGREDIENTS (10)
BENZALKONIUM CHLORIDEInactive
Quantity: 0.05 mg in 1 mL
Code: F5UM2KM3W7
Classification: IACT
BROMFENAC SODIUMActive
Quantity: 0.9 mg in 1 mL
Code: 8ECV571Y37
Classification: ACTIB
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM BORATEInactive
Code: 91MBZ8H3QO
Classification: IACT
SODIUM SULFITEInactive
Code: VTK01UQK3G
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT