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Setid 2388423e 6f29 4da6 A34d 032a1e503488 Applno 21992 Form Tablet Extended Release Oral Dosage Eq 25mg Base - Drug Product Composition: Desvenlafaxine Succinate

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$ API Ref.Price (USD/KG) : 694Xls

USFDA APPLICATION NUMBER - 21992 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 25MG BASE

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DESVENLAFAXINE SUCCINATE(UNII: ZB22ENF0XR)
(DESVENLAFAXINE - UNII:NG99554ANW)
DESVENLAFAXINE50mg

Inactive Ingredients

Ingredient Name
Actavis Pharma, Inc.
Cardinal Health
Alembic Pharmaceuticals Limited
Direct_Rx
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
Lake Erie Medical DBA Quality Care Products LLC
Lupin Pharmaceuticals, Inc.
Advagen Pharma Ltd
Bryant Ranch Prepack
Preferred Pharmaceuticals Inc.
Breckenridge Pharmaceutical, Inc
Golden State Medical Supply, Inc.
PD-Rx Pharmaceuticals, Inc.
REMEDYREPACK INC.
AMMONIA(5138Q19F1X)             
AMMONIUM LAURETH-5 SULFATE(43ZIH89I48)             
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)         
FD&C RED NO. 40(WZB9127XOA)             
FD&C YELLOW NO. 6(H77VEI93A8)          
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)  
FERROSOFERRIC OXIDE(XM0M87F357)        
HYPROMELLOSE 2208 (100 MPA.S)(B1QE5P712K)             
HYPROMELLOSE 2208 (15000 MPA.S)(Z78RG6M2N2)          
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)        
HYPROMELLOSES(3NXW29V3WO)         
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)     
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)         
POLYETHYLENE GLYCOL 6000(30IQX730WE)          
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)            
POLYETHYLENE GLYCOL 900000(16P9295IIL)             
POLYETHYLENE GLYCOL(3WJQ0SDW1A)             
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)          
POLYETHYLENE OXIDE 100000(V46Y6OJ5QB)             
POLYVINYL ALCOHOL(532B59J990)             
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)    
POVIDONE K90(RDH86HJV5Z)          
PROPYLENE GLYCOL(6DC9Q167V3)            
SHELLAC(46N107B71O)             
SILICON DIOXIDE(ETJ7Z6XBU4)        
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)