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    Drug Product Composition: Focalin

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    Focalin

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    $ API Ref.Price (USD/KG) : 6,421Xls

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    USFDA APPLICATION NUMBER - 21802 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 25MG

    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXMETHYLPHENIDATE HYDROCHLORIDE(UNII: 1678OK0E08)
    (DEXMETHYLPHENIDATE - UNII:M32RH9MFGP)     		DEXMETHYLPHENIDATE HYDROCHLORIDE15mg

    Inactive Ingredients

    Ingredient Name
    Ascent Pharmaceuticals, Inc.
    Camber Pharmaceuticals, Inc.
    Amneal Pharmaceuticals of New York LLC
    Mylan Pharmaceuticals Inc.
    American Health Packaging
    Adare Pharmaceuticals Inc
    Northstar Rx LLC
    Sun Pharmaceutical Industries, Inc.
    ACETONE(1364PS73AF)      
    ACETYLTRIBUTYL CITRATE(0ZBX0N59RZ)       
    ALCOHOL(3K9958V90M)      
    AMMONIA(5138Q19F1X)     
    AMMONIO METHACRYLATE COPOLYMER TYPE A(8GQS4E66YY)     
    AMMONIO METHACRYLATE COPOLYMER TYPE B(161H3B14U2)  
    BUTYL ALCOHOL(8PJ61P6TS3)      
    Cochineal(TZ8Z31B35M)       
    D&C Red No. 28(767IP0Y5NH)     
    D&C YELLOW NO. 10(35SW5USQ3G)     
    DEXTROSE(IY9XDZ35W2)       
    DIMETHICONE(92RU3N3Y1O)       
    ETHYLCELLULOSES(7Z8S9VYZ4B)       
    FD&C Blue No. 1(H3R47K3TBD) 
    FD&C BLUE NO. 2(L06K8R7DQK)    
    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)    
    HYDROCHLORIC ACID(QTT17582CB)      
    HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)      
    HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)(6N003M473W)       
    HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)      
    HYPROMELLOSES(3NXW29V3WO)       
    ISOPROPYL ALCOHOL(ND2M416302)      
    Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A(NX76LV5T8J)       
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(74G4R6TH13)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)(5KY68S2577)      
    POLYETHYLENE GLYCOL 6000(30IQX730WE)      
    POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)     
    POLYETHYLENE GLYCOLS(3WJQ0SDW1A)       
    POTASSIUM HYDROXIDE(WZH3C48M4T)     
    Povidone, Unspecified(FZ989GH94E)       
    PROPYLENE GLYCOL(6DC9Q167V3)  
    SHELLAC(46N107B71O) 
    SILICON DIOXIDE(ETJ7Z6XBU4)       
    SODIUM LAURYL SULFATE(368GB5141J)     
    STARCH, CORN(O8232NY3SJ)   
    SUCROSE(C151H8M554)   
    TALC(7SEV7J4R1U)
    TITANIUM DIOXIDE(15FIX9V2JP)
    TRIETHYL CITRATE(8Z96QXD6UM) 
    Water(059QF0KO0R)