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Setid 4b25a7ef 8829 4680 A19b 916ee71b40e6 Applno 21861 Form Spray Metered Nasal Dosage 0 665mg Spray - Drug Product Composition: Pataday

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

USFDA APPLICATION NUMBER - 21861 / DOSAGE - SPRAY, METERED;NASAL - 0.665MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLOPATADINE HYDROCHLORIDE(UNII: 2XG66W44KF)
(OLOPATADINE - UNII:D27V6190PM)
OLOPATADINE665ug

Inactive Ingredients

Ingredient Name
Alcon Laboratories, Inc.
Clinical Solutions Wholesale
Novartis Pharmaceuticals Corporation
Perrigo New York Inc
BENZALKONIUM CHLORIDE(F5UM2KM3W7)
EDETATE DISODIUM(7FLD91C86K)
HYDROCHLORIC ACID(QTT17582CB)
SODIUM CHLORIDE(451W47IQ8X)
SODIUM HYDROXIDE(55X04QC32I)
SODIUM PHOSPHATE, DIBASIC(GR686LBA74)
WATER(059QF0KO0R)