DORZOLAMIDE AND TIMOLOL- dorzolamide hydrochloride and timolol maleate solution

Dorzolamide and Timolol by

Drug Labeling and Warnings

Dorzolamide and Timolol by is a Prescription medication manufactured, distributed, or labeled by FDC Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DORZOLAMIDE AND TIMOLOL 
dorzolamide hydrochloride and timolol maleate solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 55545-1007
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DORZOLAMIDE HYDROCHLORIDE (UNII: QZO5366EW7) (DORZOLAMIDE - UNII:9JDX055TW1)	DORZOLAMIDE	20 mg  in 1 mL
TIMOLOL MALEATE (UNII: P8Y54F701R) (TIMOLOL ANHYDROUS - UNII:5JKY92S7BR)	TIMOLOL ANHYDROUS	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MANNITOL (UNII: 3OWL53L36A)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55545-1007-1	1 in 1 CARTON	11/16/2019
1		5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 55545-1007-2	1 in 1 CARTON	11/16/2019
2		10 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA205295	11/16/2019

Labeler - FDC Limited (650441301)

Registrant - FDC Limited (650078413)

Establishment
Name	Address	ID/FEI	Business Operations
FDC Limited		862267994	analysis(55545-1007) , manufacture(55545-1007)