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    Setid 8882dc47 F7e4 4ae7 A96b Aa09f1f1a99f Applno 20470 Form Tablet Extended Release Oral Dosage 10mg 240mg - Drug Product Composition: Loradex

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    Loradex

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    $ API Ref.Price (USD/KG) : 323Xls

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    USFDA APPLICATION NUMBER - 20470 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 10MG;240MG

    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LORATADINE(UNII: 7AJO3BO7QN)
    (LORATADINE - UNII:7AJO3BO7QN)     		LORATADINE10mg
    PSEUDOEPHEDRINE SULFATE(UNII: Y9DL7QPE6B)
    (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)     		PSEUDOEPHEDRINE SULFATE240mg

    Inactive Ingredients

    Ingredient Name
    Bryant Ranch Prepack
    REMEDYREPACK INC.
    Actavis Pharma, Inc.
    Bayer HealthCare LLC.
    Costco Wholesale Corporation
    L Perrigo Company
    TOP CARE (Topco Associates LLC)
    HyVee Inc
    Meijer Distribution Inc
    Perrigo New York Inc
    Walgreen Company
    CALCIUM CARBONATE(H0G9379FGK)         
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE(O7TSZ97GEP)          
    CANDELILLA WAX(WL0328HX19)      
    CARNAUBA WAX(R12CBM0EIZ)          
    CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)         
    ETHYLCELLULOSES(7Z8S9VYZ4B)         
    FERROSOFERRIC OXIDE(XM0M87F357)
    GLYCERYL MONOSTEARATE(230OU9XXE4)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)          
    HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)          
    HYDROXYPROPYL CELLULOSE(RFW2ET671P)          
    HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)        
    HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)        
    HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)       
    HYPROMELLOSES(3NXW29V3WO)   
    LACTOSE MONOHYDRATE(EWQ57Q8I5X)
    MAGNESIUM STEARATE(70097M6I30)
    MICROCRYSTALLINE CELLULOSE(OP1R32D61U)          
    POLYETHYLENE GLYCOL 400(B697894SGQ)        
    POLYETHYLENE GLYCOL 8000(Q662QK8M3B)        
    POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)         
    POLYETHYLENE GLYCOLS(3WJQ0SDW1A)    
    POLYSORBATE 80(6OZP39ZG8H)  
    POVIDONE(FZ989GH94E)          
    POVIDONE, UNSPECIFIED(FZ989GH94E)          
    POVIDONES(FZ989GH94E)         
    PROPYLENE GLYCOL(6DC9Q167V3) 
    SHELLAC(46N107B71O)         
    SILICON DIOXIDE(ETJ7Z6XBU4)
    SODIUM ALGINATE(C269C4G2ZQ)         
    SODIUM CITRATE(1Q73Q2JULR)         
    SODIUM CITRATE, UNSPECIFIED FORM(1Q73Q2JULR)          
    SODIUM LAURYL SULFATE(368GB5141J)  
    STARCH, CORN(O8232NY3SJ)         
    STARCH, PREGELATINIZED CORN(O8232NY3SJ)          
    SUCROSE(C151H8M554)          
    TALC(7SEV7J4R1U)
    TITANIUM DIOXIDE(15FIX9V2JP)