Bromfenac
These highlights do not include all the information needed to use Bromfenac Ophthalmic Solution safely and effectively. See full prescribing information for bromfenac. Initial U.S. Approval: 1997
Approved
Approval ID
08a0591e-6cb3-30ce-e063-6394a90a33fb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 26, 2023
Manufacturers
FDA
ARMAS PHARMACEUTICALS INC.
DUNS: 098405973
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 Code72485-649
Application NumberANDA203395
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bromfenac
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateOctober 26, 2023
FDA Product Classification
INGREDIENTS (9)
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM BORATEInactive
Code: 91MBZ8H3QO
Classification: IACT
SODIUM SULFITEInactive
Code: VTK01UQK3G
Classification: IACT
BROMFENAC SODIUMActive
Quantity: 1.035 mg in 1 mL
Code: 8ECV571Y37
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT