NDC Code(s) : 72485-634-05, 72485-634-10
Packager : ARMAS PHARMACEUTICALS INC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Brimonidine Tartrate/Timolol MaleateBrimonidine Tartrate and Timolol Maleate SOLUTION/ DROPS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72485-634
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BRIMONIDINE TARTRATE(UNII: 4S9CL2DY2H)
(BRIMONIDINE - UNII:E6GNX3HHTE) 		BRIMONIDINE TARTRATE2 mg in 1 mL
TIMOLOL MALEATE(UNII: P8Y54F701R)
(TIMOLOL ANHYDROUS - UNII:5JKY92S7BR) 		TIMOLOL ANHYDROUS5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
SODIUM PHOSPHATE(UNII: SE337SVY37)
WATER(UNII: 059QF0KO0R)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72485-634-051 in 1 CARTON 11/03/2023
15 mL in 1 BOTTLE, DROPPER Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:72485-634-101 in 1 CARTON 11/03/2023
210 mL in 1 BOTTLE, DROPPER Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201949 11/03/2023

LABELER - ARMAS PHARMACEUTICALS INC(098405973)

REGISTRANT - SENTISS AG(486920486)

Establishment
Name Address ID/FEI Business Operations
Ophtapharm AG 482198285 label(72485-634), manufacture(72485-634), pack(72485-634)

PRINCIPAL DISPLAY PANEL

NDC 72485-634-05
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution
0.2%/0.5%
Sterile
Rx only
5 mL

5 ml container

5 ml container

PRINCIPAL DISPLAY PANEL

NDC 72485-634-10
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution
0.2%/0.5%
Sterile
Rx only
10 mL

10 mL container10 mL container