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Drug Product Composition: Mesalazine

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$ API Ref.Price (USD/KG) : 47Xls

USFDA APPLICATION NUMBER - 20049 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 500MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MESALAMINE(UNII: 4Q81I59GXC)
(MESALAMINE - UNII:4Q81I59GXC)
MESALAMINE500mg | 250mg

Inactive Ingredients

Ingredient Name
American Health Packaging
Cardinal Health
Prasco Laboratories
REMEDYREPACK INC.
CASTOR OIL(D5340Y2I9G)
COLLOIDAL SILICON DIOXIDE(ETJ7Z6XBU4)   
D&C YELLOW NO. 10(35SW5USQ3G)  
DIACETYLATED MONOGLYCERIDES(5Z17386USF)   
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)   
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C GREEN NO. 3(3P3ONR6O1S)  
FERROSOFERRIC OXIDE(XM0M87F357)   
GELATIN(2G86QN327L) 
GELATIN, UNSPECIFIED(2G86QN327L)   
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)   
POTASSIUM HYDROXIDE(WZH3C48M4T)   
SHELLAC(46N107B71O)   
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(368GB5141J)   
STARCH, CORN(O8232NY3SJ)   
STEARIC ACID(4ELV7Z65AP)
SUCROSE(C151H8M554)   
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
WHITE WAX(7G1J5DA97F)