BROMFENAC
These highlights do not include all the information needed to use BROMFENAC OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for BROMFENAC OPHTHALMIC SOLUTION BROMFENAC ophthalmic solution Initial U.S. Approval: 1997
Approved
Approval ID
2120380c-81e6-43ce-9211-aad1993b9be2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 27, 2020
Manufacturers
FDA
Gland Pharma Limited
DUNS: 918601238
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 Code68083-313
Application NumberANDA211029
Marketing CategoryC73584
Route of AdministrationOPHTHALMIC
Effective DateMarch 31, 2020
Generic NameBromfenac
INGREDIENTS (10)
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
BROMFENAC SODIUMActive
Quantity: 0.9 mg in 1 mL
Code: 8ECV571Y37
Classification: ACTIM
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Quantity: 0.05 mg in 1 mL
Code: F5UM2KM3W7
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM BORATEInactive
Code: 91MBZ8H3QO
Classification: IACT
SODIUM SULFITEInactive
Code: VTK01UQK3G
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT