bromfenac ophthalmic solution
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 1997
Approved
Approval ID
246e2110-6a2d-4e22-8e37-72d80796b9af
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 31, 2023
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.
Bromfenac Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82260-602
Application NumberNDA203168
Product Classification
M
Marketing Category
C73605
G
Generic Name
Bromfenac Sodium
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJanuary 31, 2023
FDA Product Classification
INGREDIENTS (10)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Quantity: 0.05 mg in 1 mL
Code: F5UM2KM3W7
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM BORATEInactive
Code: 91MBZ8H3QO
Classification: IACT
SODIUM SULFITEInactive
Code: VTK01UQK3G
Classification: IACT
TYLOXAPOLInactive
Code: Y27PUL9H56
Classification: IACT
BROMFENAC SODIUMActive
Quantity: 0.7 mg in 1 mL
Code: 8ECV571Y37
Classification: ACTIM
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT