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Setid 9e6641a9 32c8 422a A1d6 3aba08fd1400 Applno 20929 Form Suspension Inhalation Dosage 0 5mg 2ml - Drug Product Composition: BUDESONIDE [USP-RS]

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$ API Ref.Price (USD/KG) : 3,491Xls

USFDA APPLICATION NUMBER - 20929 / DOSAGE - SUSPENSION;INHALATION - 0.5MG/2ML

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUDESONIDE(UNII: Q3OKS62Q6X)
(BUDESONIDE - UNII:Q3OKS62Q6X)
BUDESONIDE0.5mg in 2

Inactive Ingredients

Ingredient Name
Cardinal Health
The Ritedose Corporation
A-S Medication Solutions
Actavis Pharma, Inc.
American Health Packaging
Amneal Pharmaceuticals of New York LLC
Catalent Pharma Solutions, LLC
Cipla USA Inc.
Exelan Pharmaceuticals, Inc.
NorthStar RxLLC
Preferred Pharmaceuticals Inc.
Preferred Pharmaceuticals, Inc.
Apotex Corp.
ANHYDROUS CITRIC ACID(XF417D3PSL)           
CITRIC ACID MONOHYDRATE(2968PHW8QP)  
EDETATE DISODIUM(7FLD91C86K) 
POLYSORBATE 80(6OZP39ZG8H) 
SODIUM CHLORIDE (451W47IQ8X)            
SODIUM CHLORIDE(451W47IQ8X) 
SODIUM CITRATE(1Q73Q2JULR)      
SODIUM CITRATE, UNSPECIFIED FORM(1Q73Q2JULR)         
trisodium citrate dihydrate(B22547B95K)          
WATER(059QF0KO0R)