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Drug Product Composition: Budesonide 21-acetate

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$ API Ref.Price (USD/KG) : 3,434Xls

USFDA APPLICATION NUMBER - 21324 / DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - 3MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUDESONIDE(UNII: Q3OKS62Q6X)
(BUDESONIDE - UNII:Q3OKS62Q6X)
BUDESONIDE3mg

Inactive Ingredients

Ingredient Name
Teva Pharmaceuticals USA, Inc.
Alvogen, Inc.
American Health Packaging
APPCO PHARMA LLC
AstraZeneca Pharmaceuticals LP
Golden State Medical Supply, Inc.
Lake Erie Medical DBA Quality Care Products LLC
Mayne Pharma Inc.
Mylan Institutional Inc.
Mylan Pharmaceuticals Inc.
Padagis US LLC
Paddock Laboratories, LLC
Par Pharmaceutical Inc.
Zydus Pharmaceuticals USA Inc.
Amneal Pharmaceuticals LLC
ACETIC ACID(Q40Q9N063P)              
Acetyltributyl citrate(0ZBX0N59RZ) 
ALCOHOL(3K9958V90M)              
Ammonia(5138Q19F1X)              
BUTYL ALCOHOL(8PJ61P6TS3)              
CETYL ALCOHOL(936JST6JCN)             
CROSPOVIDONE (120 .MU.M)(68401960MK)              
CROSPOVIDONE(2S7830E561)             
D&C RED NO. 28(767IP0Y5NH)             
D&C RED NO. 33(9DBA0SBB0L)             
D&C YELLOW NO. 10(35SW5USQ3G)        
DIMETHICONE(92RU3N3Y1O)          
Ethyl Acrylate(71E6178C9T)              
Ethylcellulose (10 MPA.S)(3DYK7UYZ62)             
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)        
ETHYLCELLULOSES(7Z8S9VYZ4B)          
FD&C BLUE NO. 1(H3R47K3TBD)        
FD&C BLUE NO. 2(L06K8R7DQK)        
FD&C RED NO. 40(WZB9127XOA)        
FD&C YELLOW NO. 6(H77VEI93A8)             
FERRIC OXIDE RED(1K09F3G675)       
FERRIC OXIDE YELLOW(EX438O2MRT)          
FERROSOFERRIC OXIDE(XM0M87F357)  
GELATIN(2G86QN327L)         
GELATIN, UNSPECIFIED(2G86QN327L)      
Hypromellose, Unspecified(3NXW29V3WO)             
HYPROMELLOSES(3NXW29V3WO)              
INDIGOTINDISULFONATE SODIUM(D3741U8K7L)              
LACTOSE MONOHYDRATE(EWQ57Q8I5X)         
MAGNESIUM STEARATE(70097M6I30)            
Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A(NX76LV5T8J)        
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(NX76LV5T8J)           
METHACRYLIC ACID(1CS02G8656)           
METHYL ALCOHOL(Y4S76JWI15)              
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)            
POLYSORBATE 80(6OZP39ZG8H)   
POTASSIUM HYDROXIDE(WZH3C48M4T)           
PROPYLENE GLYCOL(6DC9Q167V3)      
SHELLAC(46N107B71O)    
SILICON DIOXIDE(ETJ7Z6XBU4)           
SODIUM HYDROXIDE(55X04QC32I)         
SODIUM LAURYL SULFATE(368GB5141J)       
STARCH, CORN(O8232NY3SJ)        
SUCROSE(C151H8M554)      
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIETHYL CITRATE(8Z96QXD6UM)
WATER(059QF0KO0R)