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Setid D76293c8 2642 4bfc 97bf 59e37251723d Applno 21130 Form Tablet Oral Dosage 400mg - Drug Product Composition: HY-10394

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$ API Ref.Price (USD/KG) : 614Xls

USFDA APPLICATION NUMBER - 21130 / DOSAGE - TABLET;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
linezolid(UNII: ISQ9I6J12J)
(linezolid - UNII:ISQ9I6J12J)
linezolid600mg

Inactive Ingredients

Ingredient Name
Cardinal Health
REMEDYREPACK INC.
CARNAUBA WAX(R12CBM0EIZ)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P) 
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P) 
HYDROXYPROPYL CELLULOSE(RFW2ET671P) 
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) 
HYPROMELLOSES(3NXW29V3WO)
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U) 
polyethylene glycol(3WJQ0SDW1A) 
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) 
POLYETHYLENE GLYCOLS(3WJQ0SDW1A) 
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2) 
SODIUM STARCH GLYCOLATE TYPE A(H8AV0SQX4D) 
STARCH, CORN(O8232NY3SJ)
titanium dioxide(15FIX9V2JP)