DORZOLAMIDE AND TIMOLOL- dorzolamide hydrochloride and timolol maleate solution 
FDC Limited

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Dorzolamide hydrochloride and timolol maleate ophthalmic solution

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DORZOLAMIDE AND TIMOLOL 
dorzolamide hydrochloride and timolol maleate solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55545-1007
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DORZOLAMIDE HYDROCHLORIDE (UNII: QZO5366EW7) (DORZOLAMIDE - UNII:9JDX055TW1) DORZOLAMIDE20 mg  in 1 mL
TIMOLOL MALEATE (UNII: P8Y54F701R) (TIMOLOL ANHYDROUS - UNII:5JKY92S7BR) TIMOLOL ANHYDROUS5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55545-1007-11 in 1 CARTON11/16/2019
15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:55545-1007-21 in 1 CARTON11/16/2019
210 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20529511/16/2019
Labeler - FDC Limited (650441301)
Registrant - FDC Limited (650078413)
Establishment
NameAddressID/FEIBusiness Operations
FDC Limited862267994analysis(55545-1007) , manufacture(55545-1007)

Revised: 11/2019
Document Id: 97619b26-b0db-db63-e053-2995a90abdba
Set id: 3189b866-d8ba-4ffc-a51b-20a46ce9c361
Version: 1
Effective Time: 20191115
 
FDC Limited