NDC Code(s) : 47781-136-34
Packager : ALVOGEN INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47781-136
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DORZOLAMIDE HYDROCHLORIDE(UNII: QZO5366EW7)
(DORZOLAMIDE - UNII:9JDX055TW1) 		DORZOLAMIDE22.3 mg in 1 mL
TIMOLOL MALEATE(UNII: P8Y54F701R)
(TIMOLOL ANHYDROUS - UNII:5JKY92S7BR) 		TIMOLOL ANHYDROUS6.8 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CITRATE(UNII: 1Q73Q2JULR)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)(UNII: R33S7TK2EP)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
MANNITOL(UNII: 3OWL53L36A)
WATER(UNII: 059QF0KO0R)
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:47781-136-341 in 1 CARTON
110 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091180 12/17/2013

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL