DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATE (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container Label

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Carton Label

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DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
dorzolamide hydrochloride and timolol maleate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70069-051
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DORZOLAMIDE HYDROCHLORIDE (DORZOLAMIDE) DORZOLAMIDE 20 mg in 1 mL
TIMOLOL MALEATE (TIMOLOL ANHYDROUS) TIMOLOL ANHYDROUS 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE
TRISODIUM CITRATE DIHYDRATE
MANNITOL
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)
SODIUM HYDROXIDE
WATER
Product Characteristics
Color WHITE (A clear, colorless to nearly colorless solution) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70069-051-12 12 CARTON in 1 BOX contains a CARTON (70069-051-01)
1 NDC:70069-051-01 1 BOTTLE in 1 CARTON This package is contained within the BOX (70069-051-12) and contains a BOTTLE
1 10 mL in 1 BOTTLE This package is contained within a CARTON (70069-051-01) and a BOX (70069-051-12)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207523 06/25/2019
Labeler — Somerset Therapeutics, LLC (079947873)
Registrant — Somerset Therapeutics, LLC (079947873)
Establishment
Name Address ID/FEI Operations
Wintac Limited 677236695 ANALYSIS (70069-051), LABEL (70069-051), MANUFACTURE (70069-051), PACK (70069-051)

Revised: 03/2021 Somerset Therapeutics, LLC

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