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
NDC Product Code72485-649
Application NumberANDA203395
Marketing CategoryC73584
Route of AdministrationOPHTHALMIC
Effective DateOctober 26, 2023
Generic NameBromfenac
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