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Setid 98d81fc6 4482 45e5 8106 4dfd56f3433b Applno 18086 Form Solution Drops Ophthalmic Dosage Eq 0 25 Base - Drug Product Composition: Timolol

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$ API Ref.Price (USD/KG) : 927Xls

USFDA APPLICATION NUMBER - 18086 / DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.25% BASE

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Timolol Maleate(UNII: P8Y54F701R)
(Timolol Anhydrous - UNII:5JKY92S7BR)
Timolol Anhydrous5mg in 1 | 2.5mg in 1

Inactive Ingredients

Ingredient Name
Apotex Corp.
Aton Pharma, Inc.
Bausch & Lomb Incorporated
NuCare Pharmaceuticals,Inc.
REMEDYREPACK INC.
REMEDYREPACK INC.
Benzalkonium Chloride(F5UM2KM3W7) 
HYDROCHLORIC ACID(QTT17582CB)     
SODIUM CHLORIDE(451W47IQ8X)   
SODIUM HYDROXIDE(55X04QC32I) 
SODIUM PHOSPHATE, DIBASIC(GR686LBA74)  
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE(E1W4N241FO)    
SODIUM PHOSPHATE, MONOBASIC(3980JIH2SW)  
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE(5QWK665956)    
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM(3980JIH2SW)     
Water(059QF0KO0R)