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Setid 80fa20dc B181 48be 83ce D66a83753878 Applno 21516 Form Solution Drops Ophthalmic Dosage Eq 0 5 Base - Drug Product Composition: Timolol Maleate

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$ API Ref.Price (USD/KG) : 1,118Xls

USFDA APPLICATION NUMBER - 21516 / DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.5% BASE

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
timolol maleate(UNII: P8Y54F701R)
(timolol - UNII:817W3C6175)
timolol5mg in 1

Inactive Ingredients

Ingredient Name
Apotex Corp.
Aton Pharma, Inc.
Bausch & Lomb Incorporated
Hi-Tech Pharmacal Co., Inc.
ISTA PHARMACEUTICALS, INC.
NuCare Pharmaceuticals,Inc.
REMEDYREPACK INC.
REMEDYREPACK INC.
BENZALKONIUM CHLORIDE(F5UM2KM3W7) 
hydrochloric acid(QTT17582CB)       
potassium sorbate(1VPU26JZZ4)       
Sodium Chloride(451W47IQ8X)    
SODIUM HYDROXIDE(55X04QC32I)  
Sodium Phosphate, Dibasic(GR686LBA74)   
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE(E1W4N241FO)      
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM(GR686LBA74)       
SODIUM PHOSPHATE, MONOBASIC(3980JIH2SW)   
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE(5QWK665956)      
Sodium Phosphate, Monobasic, Monohydrate(593YOG76RN)       
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM(3980JIH2SW)       
Water(059QF0KO0R)