Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Physicians Total Care, Inc.
Physicians Total Care, Inc.
194123980
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Bromfenac
Product Details
NDC Product Code
54868-6343Application Number
ANDA201211Marketing Category
ANDA (C73584)Route of Administration
OPHTHALMICEffective Date
April 17, 2012Benzalkonium chlorideInactive
Code: F5UM2KM3W7Class: IACTQuantity: 0.05 mg in 1 mL
povidoneInactive
Code: FZ989GH94EClass: IACTQuantity: 20 mg in 1 mL
sodium borateInactive
Code: 91MBZ8H3QOClass: IACTQuantity: 11 mg in 1 mL
waterInactive
Code: 059QF0KO0RClass: IACT
sodium sulfiteInactive
Code: VTK01UQK3GClass: IACTQuantity: 2 mg in 1 mL
Boric acidInactive
Code: R57ZHV85D4Class: IACTQuantity: 11 mg in 1 mL
BromfenacActive
Code: 8ECV571Y37Class: ACTIBQuantity: 1.035 mg in 1 mL
edetate disodiumInactive
Code: 7FLD91C86KClass: IACTQuantity: 0.2 mg in 1 mL
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACTQuantity: 1.5 mg in 1 mL
sodium hydroxideInactive
Code: 55X04QC32IClass: IACT