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Setid F55bcc41 2e8d 4ee5 9993 05c7d86f2d2c Applno 21618 Form Tablet Oral Dosage 250mg - Drug Product Composition: DSSTox_CID_3676

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$ API Ref.Price (USD/KG) : 13Xls

USFDA APPLICATION NUMBER - 21618 / DOSAGE - TABLET;ORAL - 250MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tinidazole(UNII: 033KF7V46H)
(Tinidazole - UNII:033KF7V46H)
Tinidazole500mg | 250mg

Inactive Ingredients

Ingredient Name
Biocomp Pharma, Inc.
Lupin Pharmaceuticals,Inc.
West-Ward Pharmaceuticals Corp.
Ingenus Pharmaceuticals NJ, LLC
Aluminum Oxide(LMI26O6933)   
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)  
COPOVIDONE K25-31(D9C330MD8B)   
CROSCARMELLOSE SODIUM(M28OL1HH48)
FD&C Red No. 40(WZB9127XOA)  
FD&C Yellow No. 6(H77VEI93A8)   
FERRIC OXIDE YELLOW(EX438O2MRT)   
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)   
Hypromelloses(3NXW29V3WO)   
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)  
Polydextrose(VH2XOU12IE)   
POLYETHYLENE GLYCOL 3000(SA1B764746)   
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)  
Polyethylene Glycols(3WJQ0SDW1A)   
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)  
POVIDONE K30(U725QWY32X)   
SILICON DIOXIDE(ETJ7Z6XBU4)  
STARCH, CORN(O8232NY3SJ) 
TALC(7SEV7J4R1U)  
TITANIUM DIOXIDE(15FIX9V2JP)
Triacetin(XHX3C3X673)   
WATER(059QF0KO0R)