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Drug Product Composition: Dexamethasone

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$ API Ref.Price (USD/KG) : 698Xls

USFDA APPLICATION NUMBER - 21537 / DOSAGE - SUSPENSION/DROPS;OTIC - 0.3%;0.1%

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ciprofloxacin Hydrochloride(UNII: 4BA73M5E37)
(Ciprofloxacin - UNII:5E8K9I0O4U)
Ciprofloxacin3mg in 1
Dexamethasone(UNII: 7S5I7G3JQL)
(Dexamethasone - UNII:7S5I7G3JQL)
Dexamethasone1mg in 1

Inactive Ingredients

Ingredient Name
Alcon Laboratories, Inc.
ARMAS PHARMACEUTICALS INC.
Clinical Solutions Wholesale
NuCare Pharmaceuticals,Inc.
Acetic Acid(Q40Q9N063P)
BENZALKONIUM CHLORIDE(F5UM2KM3W7)
BORIC ACID(R57ZHV85D4)
EDETATE DISODIUM(7FLD91C86K)
Hydrochloric Acid(QTT17582CB)
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%)(L605B5892V)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED(T4V6TWG28D)   
SODIUM ACETATE(4550K0SC9B)
SODIUM CHLORIDE(451W47IQ8X)
SODIUM HYDROXIDE(55X04QC32I)
Tyloxapol(Y27PUL9H56)
WATER(059QF0KO0R)