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Drug Product Composition: Oroken

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$ API Ref.Price (USD/KG) : 148Xls

USFDA APPLICATION NUMBER - 203195 / DOSAGE - CAPSULE;ORAL - 400MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFIXIME(UNII: 97I1C92E55)
(CEFIXIME ANHYDROUS - UNII:XZ7BG04GJX)
CEFIXIME ANHYDROUS400mg

Inactive Ingredients

Ingredient Name
Ascend Laboratories, LLC
LUPIN LIMITED
Lupin Pharmaceuticals, Inc.
PD-Rx Pharmaceuticals, Inc.
REMEDYREPACK INC.
ALCOHOL(3K9958V90M)    
ALUMINUM OXIDE(LMI26O6933)    
AMMONIA(5138Q19F1X)    
ASPARTAME(Z0H242BBR1)    
BUTYL ALCOHOL(8PJ61P6TS3)    
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)    
CROSCARMELLOSE SODIUM(M28OL1HH48)   
CROSPOVIDONE(2S7830E561)  
CROSPOVIDONE(68401960MK)    
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(O7TSZ97GEP)    
FD&C RED NO. 40(WZB9127XOA)    
FERRIC OXIDE RED(1K09F3G675)
FERROSOFERRIC OXIDE(XM0M87F357)
GELATIN(2G86QN327L)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(2165RE0K14)
HYPROMELLOSES(3NXW29V3WO)    
ISOPROPYL ALCOHOL(ND2M416302)    
LACTOSE MONOHYDRATE(EWQ57Q8I5X)    
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)    
POTASSIUM HYDROXIDE(WZH3C48M4T)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O) 
SHELLAC(MB5IUD6JUA)    
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM BENZOATE(OJ245FE5EU)   
SODIUM LAURYL SULFATE(368GB5141J)
STARCH, PREGELATINIZED CORN(O8232NY3SJ)    
STRAWBERRY(4J2TY8Y81V)   
SUCRALOSE(96K6UQ3ZD4)    
SUCROSE(C151H8M554)   
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)    
XANTHAN GUM(TTV12P4NEE)