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Drug Product Composition: Diclofenac Sodium

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$ API Ref.Price (USD/KG) : 25Xls

USFDA APPLICATION NUMBER - 20254 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICLOFENAC SODIUM(UNII: QTG126297Q)
(DICLOFENAC - UNII:144O8QL0L1)
DICLOFENAC SODIUM100mg

Inactive Ingredients

Ingredient Name
Bryant Ranch Prepack
Lake Erie Medical DBA Quality Care Products LLC
PD-Rx Pharmaceuticals, Inc.
Preferred Pharmaceuticals, Inc.
Proficient Rx LP
Sandoz Inc
CETYL ALCOHOL(936JST6JCN)
FERRIC OXIDE RED(1K09F3G675)
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)     
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)     
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)   
HYDROXYPROPYL CELLULOSE(RFW2ET671P)     
MAGNESIUM STEARATE(70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)    
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)  
POVIDONE(FZ989GH94E)     
POVIDONE, UNSPECIFIED(FZ989GH94E)    
POVIDONES(FZ989GH94E)   
SILICON DIOXIDE(ETJ7Z6XBU4)
SUCROSE(C151H8M554)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)