Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Woodstock Sterile Solutions, Inc.
Sun Pharmaceutical Industries, Inc.
117895702
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
BROMSITE 0.075%
Product Details
NDC Product Code
49708-754Application Number
NDA206911Marketing Category
NDA (C73594)Route of Administration
OPHTHALMICEffective Date
April 14, 2023BromfenacActive
Code: 8ECV571Y37Class: ACTIMQuantity: 0.76 mg in 1 mL
BORIC ACIDInactive
Code: R57ZHV85D4Class: IACT
SODIUM BORATEInactive
Code: 91MBZ8H3QOClass: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2Class: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
POLYCARBOPHILInactive
Code: W25LM17A4WClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7Class: IACTQuantity: 0.05 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT