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Setid Ce00e4d9 178b 4ae1 Af76 4042f7e6c822 Applno 22253 Form Tablet Oral Dosage 50mg - Drug Product Composition: Lacosamide

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$ API Ref.Price (USD/KG) : 419Xls

USFDA APPLICATION NUMBER - 22253 / DOSAGE - TABLET;ORAL - 50MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LACOSAMIDE(UNII: 563KS2PQY5)
(LACOSAMIDE - UNII:563KS2PQY5)
LACOSAMIDE100mg

Inactive Ingredients

Ingredient Name
Alembic Pharmaceuticals Inc.
Florida Pharmaceutical Products, LLC
Indoco Remedies Limited
Natco Pharma Limited
NorthStar RxLLC
Tris Pharma Inc
Glenmark Pharmaceuticals Inc. USA
REMEDYREPACK INC.
Ascend Laboratories, LLC
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)   
CROSPOVIDONE (120 .MU.M)(68401960MK)        
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)       
CROSPOVIDONE(2S7830E561)       
CROSPOVIDONE(68401960MK)     
FD&C BLUE NO. 2(L06K8R7DQK) 
FERRIC OXIDE RED(1K09F3G675) 
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357) 
HYDROXYPROPYL CELLULOSE (110000 WAMW)(5Y0974F5PW)        
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)       
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UKE75GEA7F)        
HYDROXYPROPYL CELLULOSE(RFW2ET671P)     
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(2165RE0K14)    
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)        
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)        
HYPROMELLOSES(3NXW29V3WO)        
ISOPROPYL ALCOHOL(ND2M416302)     
LECITHIN, SOYBEAN(1DI56QDM62)        
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED(2165RE0K14)       
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)      
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)       
POLYETHYLENE GLYCOL 400(B697894SGQ)        
POLYETHYLENE GLYCOL 6000(30IQX730WE)        
POLYETHYLENE GLYCOL(3WJQ0SDW1A)      
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)       
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)        
POLYVINYL ALCOHOL(532B59J990)     
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)     
SILICON DIOXIDE(ETJ7Z6XBU4)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)