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Setid Fa5ad0ca 545c 443d Afa1 4f5b8ce4de89 Applno 21545 Form Solution Drops Ophthalmic Dosage Eq 0 2 Base - Drug Product Composition: Pataday

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$ API Ref.Price (USD/KG) : 5,119Xls

USFDA APPLICATION NUMBER - 21545 / DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.2% BASE

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLOPATADINE HYDROCHLORIDE(UNII: 2XG66W44KF)
(OLOPATADINE - UNII:D27V6190PM)
OLOPATADINE2mg in 1

Inactive Ingredients

Ingredient Name
Alcon Laboratories, Inc.
Apotex Corp.
Aurobindo Pharma Limited
Cipla USA Inc.
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
Sandoz Inc
Teva Pharmaceuticals USA, Inc.
BENZALKONIUM CHLORIDE(F5UM2KM3W7)
EDETATE DISODIUM(7FLD91C86K)
HYDROCHLORIC ACID (QTT17582CB)      
HYDROCHLORIC ACID(QTT17582CB)  
POVIDONE K30(U725QWY32X)     
POVIDONE(FZ989GH94E)    
POVIDONE, UNSPECIFIED(FZ989GH94E)     
SODIUM CHLORIDE (451W47IQ8X)      
SODIUM CHLORIDE(451W47IQ8X) 
SODIUM HYDROXIDE(55X04QC32I) 
SODIUM PHOSPHATE, DIBASIC(GR686LBA74)    
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS(22ADO53M6F)     
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (GR686LBA74)      
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM(GR686LBA74)      
WATER(059QF0KO0R)