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Setid 6578cdbf 1c06 4fb3 93f6 93383be8db21 Applno 21856 Form Tablet Oral Dosage 40mg - Drug Product Composition: Febuxostat

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$ API Ref.Price (USD/KG) : 329Xls

USFDA APPLICATION NUMBER - 21856 / DOSAGE - TABLET;ORAL - 40MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FEBUXOSTAT(UNII: 101V0R1N2E)
(FEBUXOSTAT - UNII:101V0R1N2E)
FEBUXOSTAT40mg

Inactive Ingredients

Ingredient Name
Solco Healthcare US LLC
Mylan Pharmaceuticals Inc.
Avera McKennan Hospital
Indoco Remedies Limited
REMEDYREPACK INC.
AbbVie Inc.
Cardinal Health
Lannett Company, Inc.
ALUMINUM OXIDE(LMI26O6933)       
ANHYDROUS LACTOSE(3SY5LH9PMK)       
cellulose, microcrystalline(OP1R32D61U)     
CROSCARMELLOSE SODIUM(M28OL1HH48)
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)       
D&C YELLOW NO. 10(35SW5USQ3G)       
FD&C BLUE NO. 1(H3R47K3TBD)       
FD&C BLUE NO. 2(L06K8R7DQK)      
FERRIC OXIDE YELLOW(EX438O2MRT)       
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)       
HYDROXYPROPYL CELLULOSE (1200000 WAMW)(U3JF91U133)       
Hydroxypropyl Cellulose (1600000 WAMW)(RFW2ET671P)     
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)       
HYDROXYPROPYL CELLULOSE(RFW2ET671P)      
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)       
lactose monohydrate(EWQ57Q8I5X) 
magnesium stearate(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)   
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)       
POLYETHYLENE GLYCOL(3WJQ0SDW1A)      
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)       
POLYVINYL ALCOHOL(532B59J990)      
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)       
SILICON DIOXIDE(ETJ7Z6XBU4) 
SODIUM LAURYL SULFATE(368GB5141J)       
TALC(7SEV7J4R1U)    
TITANIUM DIOXIDE(15FIX9V2JP)