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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) | MESALAMINE | 500mg | 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) |
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