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Drug Product Composition: Tenofovir Disoproxil Fumarate

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$ API Ref.Price (USD/KG) : 154Xls

USFDA APPLICATION NUMBER - 21356 / DOSAGE - TABLET;ORAL - 300MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TENOFOVIR DISOPROXIL FUMARATE(UNII: OTT9J7900I)
(TENOFOVIR ANHYDROUS - UNII:W4HFE001U5)
TENOFOVIR DISOPROXIL FUMARATE300mg

Inactive Ingredients

Ingredient Name
A-S Medication Solutions
REMEDYREPACK INC.
Apotex Corp.
Cipla USA Inc.
American Health Packaging
Teva Pharmaceuticals USA, Inc.
ALUMINUM OXIDE(LMI26O6933)    
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)  
CROSCARMELLOSE SODIUM(M28OL1HH48) 
CROSPOVIDONE, UNSPECIFIED(2S7830E561)    
FD&C BLUE NO. 2(L06K8R7DQK) 
FD&C RED NO. 40(WZB9127XOA)    
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W)   
HYPROMELLOSE 2910 (15000 MPA.S)(288VBX44JC)    
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)     
HYPROMELLOSES(3NXW29V3WO)     
INDIGOTINDISULFONATE SODIUM(D3741U8K7L)    
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)    
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)   
POLYETHYLENE GLYCOL 400(B697894SGQ)     
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)    
POLYSORBATE 80(6OZP39ZG8H)     
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)    
POVIDONE K30(U725QWY32X)    
SILICON DIOXIDE(ETJ7Z6XBU4)    
STARCH, CORN(O8232NY3SJ) 
TALC(7SEV7J4R1U)    
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)