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Drug Product Composition: Amphetamine Aspartate

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$ API Ref.Price (USD/KG) : 2,479Xls

USFDA APPLICATION NUMBER - 21303 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 3.75MG;3.75MG;3.75MG;3.75MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMPHETAMINE ASPARTATE MONOHYDRATE(UNII: O1ZPV620O4)
(AMPHETAMINE - UNII:CK833KGX7E)
AMPHETAMINE ASPARTATE MONOHYDRATE1.25mg | 2.5mg | 3.75mg | 5mg | 6.25mg | 7.5mg
AMPHETAMINE SULFATE(UNII: 6DPV8NK46S)
(AMPHETAMINE - UNII:CK833KGX7E)
AMPHETAMINE SULFATE1.25mg | 2.5mg | 3.75mg | 5mg | 6.25mg | 7.5mg
DEXTROAMPHETAMINE SACCHARATE(UNII: G83415V073)
(DEXTROAMPHETAMINE - UNII:TZ47U051FI)
DEXTROAMPHETAMINE SACCHARATE1.25mg | 2.5mg | 3.75mg | 5mg | 6.25mg | 7.5mg
DEXTROAMPHETAMINE SULFATE(UNII: JJ768O327N)
(DEXTROAMPHETAMINE - UNII:TZ47U051FI)
DEXTROAMPHETAMINE SULFATE1.25mg | 2.5mg | 3.75mg | 5mg | 6.25mg | 7.5mg

Inactive Ingredients

Ingredient Name
Par Pharmaceutical, Inc.
American Health Packaging
Amneal Pharmaceuticals of New York LLC
Ascent Pharmaceuticals, Inc
Bryant Ranch Prepack
Actavis Pharma, Inc.
Zydus Pharmaceuticals (USA) Inc.
Amerigen Pharmaceuticals Inc.
Barr Laboratories Inc.
Sun Pharmaceutical Industries, Inc.
ALCOHOL(3K9958V90M)         
AMMONIA(5138Q19F1X)     
AMMONIO METHACRYLATE COPOLYMER TYPE A(8GQS4E66YY)         
AMMONIO METHACRYLATE COPOLYMER TYPE B(161H3B14U2)         
BUTYL ALCOHOL(8PJ61P6TS3)         
CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES(U72Q2I8C85)         
D&C RED NO. 28(767IP0Y5NH)         
D&C RED NO. 33(9DBA0SBB0L)         
D&C YELLOW NO. 10 ALUMINUM LAKE(CQ3XH3DET6)         
D&C YELLOW NO. 10(35SW5USQ3G)       
DEHYDRATED ALCOHOL(3K9958V90M)         
FD&C BLUE NO. 1 ALUMINUM LAKE(J9EQA3S2JM)         
FD&C BLUE NO. 1(H3R47K3TBD)    
FD&C BLUE NO. 2(L06K8R7DQK)     
FD&C BLUE NO. 2--ALUMINUM LAKE(4AQJ3LG584)         
FD&C RED NO. 3(PN2ZH5LOQY)         
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)     
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)        
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)       
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)       
HYPROMELLOSE 2910 (50 MPA.S)(1IVH67816N)        
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)        
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)       
HYPROMELLOSES(3NXW29V3WO)        
ISOPROPYL ALCOHOL(ND2M416302)       
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)       
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2)(XRK36F13ZZ)         
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(74G4R6TH13)       
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)(5KY68S2577)         
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(NX76LV5T8J)        
METHACRYLIC ACID-ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)         
POLYDEXTROSE(VH2XOU12IE)        
POLYETHYLENE GLYCOL 400(B697894SGQ)         
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)        
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)         
POLYSORBATE 80(6OZP39ZG8H)         
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)         
POTASSIUM HYDROXIDE(WZH3C48M4T)     
PROPYLENE GLYCOL(6DC9Q167V3)   
SHELLAC(46N107B71O)   
SILICON DIOXIDE(ETJ7Z6XBU4)         
SODIUM LAURYL SULFATE(368GB5141J)         
STARCH, CORN(O8232NY3SJ)      
SUCROSE(C151H8M554)  
TALC(7SEV7J4R1U)
Tert-butyl alcohol(MD83SFE959)         
TITANIUM DIOXIDE(15FIX9V2JP) 
TRIACETIN(XHX3C3X673)        
TRIETHYL CITRATE(8Z96QXD6UM)
WATER(059QF0KO0R)