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    Setid D6fbffab A5f1 494e 87e7 793aa4e25b3d Applno 50791 Form Tablet Delayed Release Oral Dosage Eq 180mg Base - Drug Product Composition: Mycophenolate Sodium

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    Mycophenolate Sodium

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    $ API Ref.Price (USD/KG) : 242Xls

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    USFDA APPLICATION NUMBER - 50791 / DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 180MG BASE

    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MYCOPHENOLATE SODIUM(UNII: WX877SQI1G)
    (MYCOPHENOLIC ACID - UNII:HU9DX48N0T)     		MYCOPHENOLIC ACID180mg

    Inactive Ingredients

    Ingredient Name
    Teva Pharmaceuticals USA, Inc.
    Avera McKennan Hospital
    Biocon Pharma Inc.
    PD-Rx Pharmaceuticals, Inc.
    TWi Pharmaceuticals, Inc.
    Accord Healthcare Inc.
    Advagen Pharma Limited
    CONCORD BIOTECH LIMITED
    Lupin Pharmaceuticals, Inc.
    Slate Run Pharmaceuticals, LLC
    ALUMINUM OXIDE(LMI26O6933)         
    ANHYDROUS LACTOSE(3SY5LH9PMK)     
    CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)         
    CROSCARMELLOSE SODIUM(M28OL1HH48)      
    CROSPOVIDONE (12 MPA.S AT 5%)(40UAA97IT9)         
    Crospovidone (35 .Mu.M)(40UAA97IT9)         
    CROSPOVIDONE(2S7830E561)       
    CROSPOVIDONE(68401960MK)         
    D&C YELLOW NO. 10(35SW5USQ3G)         
    FD&C BLUE NO. 1--ALUMINUM LAKE(J9EQA3S2JM)         
    FD&C BLUE NO. 2(L06K8R7DQK)    
    Fd&C Blue No. 2--Aluminum Lake(4AQJ3LG584)         
    FD&C YELLOW NO. 6(H77VEI93A8)       
    Ferric Oxide Red(1K09F3G675)    
    FERRIC OXIDE YELLOW(EX438O2MRT)  
    FERROSOFERRIC OXIDE(XM0M87F357)      
    GLYCERYL MONO AND DICAPRYLOCAPRATE(U72Q2I8C85)         
    HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W)        
    HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)        
    HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)        
    Hypromellose Phthalate (24% Phthalate, 55 Cst)(87Y6436BKR)      
    HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)(G4U024CQK6)         
    HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)         
    HYPROMELLOSES(3NXW29V3WO)        
    LACTOSE MONOHYDRATE(EWQ57Q8I5X)       
    MAGNESIUM STEARATE(70097M6I30)
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)         
    METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(NX76LV5T8J)       
    MICROCRYSTALLINE CELLULOSE(OP1R32D61U)       
    POLYETHYLENE GLYCOL 3350(G2M7P15E5P)         
    POLYETHYLENE GLYCOL 400(B697894SGQ)         
    POLYETHYLENE GLYCOL 4000(4R4HFI6D95)       
    POLYVINYL ALCOHOL GRAFT POLYETHYLENE GLYCOL COPOLYMER (3:1; 45000 MW)(23ZQ42JZZH)         
    POLYVINYL ALCOHOL(532B59J990)         
    POVIDONE K25(K0KQV10C35)         
    POVIDONE K30(U725QWY32X)  
    POVIDONE(FZ989GH94E)         
    POVIDONE, UNSPECIFIED(FZ989GH94E)         
    PROPYLENE GLYCOL(6DC9Q167V3)       
    SHELLAC(46N107B71O)         
    SILICON DIOXIDE(ETJ7Z6XBU4)  
    SODIUM BICARBONATE(8MDF5V39QO)      
    SODIUM LAURYL SULFATE(368GB5141J)      
    STARCH, CORN(O8232NY3SJ)    
    TALC(7SEV7J4R1U)  
    TITANIUM DIOXIDE(15FIX9V2JP)
    TRIACETIN(XHX3C3X673)        
    TRIETHYL CITRATE(8Z96QXD6UM)