Bromfenac
Bromfenac Ophthlamic Solution
Approved
Approval ID
db335cea-4bfb-4905-9cab-a95fcf0051a2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 17, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Bromfenac sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6343
Application NumberANDA201211
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bromfenac sodium
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateApril 17, 2012
FDA Product Classification
INGREDIENTS (10)
Benzalkonium chlorideInactive
Quantity: 0.05 mg in 1 mL
Code: F5UM2KM3W7
Classification: IACT
povidoneInactive
Quantity: 20 mg in 1 mL
Code: FZ989GH94E
Classification: IACT
sodium borateInactive
Quantity: 11 mg in 1 mL
Code: 91MBZ8H3QO
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium sulfiteInactive
Quantity: 2 mg in 1 mL
Code: VTK01UQK3G
Classification: IACT
Boric acidInactive
Quantity: 11 mg in 1 mL
Code: R57ZHV85D4
Classification: IACT
Bromfenac sodiumActive
Quantity: 1.035 mg in 1 mL
Code: 8ECV571Y37
Classification: ACTIB
edetate disodiumInactive
Quantity: 0.2 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
polysorbate 80Inactive
Quantity: 1.5 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT