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Setid 1bb9b8d5 Eed6 45cb B1b9 E43d3ee6fecd Applno 19955 Form Tablet Oral Dosage 0 2mg - Drug Product Composition: Presinex

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$ API Ref.Price (USD/KG) : 285,513Xls

USFDA APPLICATION NUMBER - 19955 / DOSAGE - TABLET;ORAL - 0.2MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Desmopressin Acetate(UNII: XB13HYU18U)
(Desmopressin - UNII:ENR1LLB0FP)
Desmopressin0.2mg | 0.1mg

Inactive Ingredients

Ingredient Name
American Health Packaging
AvPAK
BluePoint Laboratories
Bryant Ranch Prepack
Glenmark Pharmaceuticals Inc.,USA
Impax Generics
KVK-TECH, INC.
Mylan Institutional Inc.
NCS HealthCare of KY, Inc dba Vangard Labs
Teva Pharmaceuticals USA, Inc.
Ferring Pharmaceuticals Inc.
sanofi-aventis U.S. LLC
BUTYLATED HYDROXYANISOLE(REK4960K2U)        
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K)        
CROSPOVIDONE(2S7830E561)           
CROSPOVIDONE(68401960MK)         
LACTOSE MONOHYDRATE(EWQ57Q8I5X)  
lactose(J2B2A4N98G)          
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)           
MAGNESIUM STEARATE(70097M6I30)
POVIDONE K30(U725QWY32X)          
povidone(FZ989GH94E)       
POVIDONE, UNSPECIFIED(FZ989GH94E)          
POVIDONES(FZ989GH94E)         
SILICON DIOXIDE(ETJ7Z6XBU4)        
STARCH, CORN(O8232NY3SJ)      
starch, potato (8I089SAH3T)           
STARCH, POTATO(8I089SAH3T)     
TALC(7SEV7J4R1U)