BROMSITE
These highlights do not include all the information needed to use BROMSITEsafely and effectively. See full prescribing information for BROMSITE.BROMSITE (bromfenac ophthalmic solution) 0.075%, for topical ophthalmic useInitial U.S. Approval: 1997
Approved
Approval ID
144a5072-341b-4591-8705-773b63044bcc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 14, 2023
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
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 Code49708-754
Application NumberNDA206911
Product Classification
M
Marketing Category
C73594
G
Generic Name
bromfenac
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateApril 14, 2023
FDA Product Classification
INGREDIENTS (12)
BROMFENAC SODIUMActive
Quantity: 0.76 mg in 1 mL
Code: 8ECV571Y37
Classification: ACTIM
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
SODIUM BORATEInactive
Code: 91MBZ8H3QO
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
POLYCARBOPHILInactive
Code: W25LM17A4W
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Quantity: 0.05 mg in 1 mL
Code: F5UM2KM3W7
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT