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Setid 78d7f193 583d 4dca 9d3c 6af81fbae2f4 Applno 22307 Form Tablet Oral Dosage Eq 10mg Base - Drug Product Composition: Prasugrel Hydrochloride

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$ API Ref.Price (USD/KG) : 3,638Xls

USFDA APPLICATION NUMBER - 22307 / DOSAGE - TABLET;ORAL - EQ 10MG BASE

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Prasugrel hydrochloride(UNII: G89JQ59I13)
(Prasugrel - UNII:34K66TBT99)
Prasugrel10mg

Inactive Ingredients

Ingredient Name
Cardinal Health
Lupin Pharmaceuticals, Inc.
A-S Medication Solutions
American Health Packaging
Apotex Corp.
Eli Lilly and Company
Panacea Biotec Limited
Prasco Laboratories
Sunshine Lake Pharma Co., Ltd.
Unichem Pharmaceuticals (USA), Inc.
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)        
DIETHYL PHTHALATE(UF064M00AF)         
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)         
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT) 
FERROSOFERRIC OXIDE(XM0M87F357)         
GLYCERYL BEHENATE/EICOSADIOATE(73CJJ317SR)       
GLYCERYL DIBEHENATE(R8WTH25YS2)   
HYDROCHLORIC ACID(QTT17582CB)         
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(2165RE0K14)       
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)         
HYPROMELLOSE 2208 (100 MPA.S)(B1QE5P712K)         
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W)        
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)         
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)        
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)    
HYPROMELLOSES(3NXW29V3WO)        
LACTOSE MONOHYDRATE(EWQ57Q8I5X)    
LACTOSE(J2B2A4N98G)         
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)         
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 120000 MW)(NZ94SDL6WR)         
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED(2165RE0K14)      
MANNITOL(3OWL53L36A)
MICROCRYSTALLINE CELLULOSE 102(PNR0YF693Y)         
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)   
STEARIC ACID(4ELV7Z65AP)       
SUCROSE STEARATE(274KW0O50M)   
TALC(7SEV7J4R1U)        
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)