NDC Code(s) : 72485-649-71
Packager : ARMAS PHARMACEUTICALS INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BromfenacBromfenac SOLUTION/ DROPS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72485-649
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BROMFENAC SODIUM(UNII: 8ECV571Y37)
(BROMFENAC - UNII:864P0921DW) 		BROMFENAC1.035 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BORIC ACID(UNII: R57ZHV85D4)
EDETATE DISODIUM(UNII: 7FLD91C86K)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POVIDONE K30(UNII: U725QWY32X)
SODIUM BORATE(UNII: 91MBZ8H3QO)
SODIUM SULFITE(UNII: VTK01UQK3G)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color yellow (clear, yellow to orange yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72485-649-711 in 1 CARTON 26/10/2023
11.7 mL in 1 BOTTLE, DROPPER Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203395 10/26/2023

LABELER - ARMAS PHARMACEUTICALS INC.(098405973)

REGISTRANT - SENTISS AG(486920486)

Establishment
Name Address ID/FEI Business Operations
Ophtapharm AG 482198285 manufacture(72485-649)

PRINCIPAL DISPLAY PANEL

NDC 72485-649-71

Bromfenac Ophthalmic Solution 0.09%

Once Daily

For topical application in the eye.

Rx only Sterile

1.7 mL

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