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USFDA APPLICATION NUMBER - 20610 / DOSAGE - CAPSULE;ORAL - 750MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| BALSALAZIDE DISODIUM(UNII: 1XL6BJI034) (balsalazide - UNII:P80AL8J7ZP) | BALSALAZIDE DISODIUM | 750mg |
Inactive Ingredients
| Ingredient Name | American Health Packaging | Apotex Corp. | AvKARE | AvPAK | Clinical Solutions Wholesale | Golden State Medical Supply, Inc. | Hikma Pharmaceuticals USA Inc. | Cardinal Health | Mylan Pharmaceuticals Inc. | Clinical Solutions Wholesale, LLC | Oceanside Pharmaceuticals | Zydus Lifesciences Limited | Zydus Pharmaceuticals (USA) Inc. |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| AMMONIA(5138Q19F1X) | |||||||||||||
| BUTYL ALCOHOL(8PJ61P6TS3) | |||||||||||||
| colloidal silicon dioxide(ETJ7Z6XBU4) | |||||||||||||
| D&C RED NO. 28(767IP0Y5NH) | |||||||||||||
| D&C YELLOW NO. 10(35SW5USQ3G) | |||||||||||||
| FD&C BLUE NO. 1(H3R47K3TBD) | |||||||||||||
| FD&C BLUE NO. 2(L06K8R7DQK) | |||||||||||||
| FD&C RED NO. 40(WZB9127XOA) | |||||||||||||
| FD&C YELLOW NO. 6(H77VEI93A8) | |||||||||||||
| FERRIC OXIDE RED(1K09F3G675) | |||||||||||||
| FERROSOFERRIC OXIDE(XM0M87F357) | |||||||||||||
| GELATIN(2G86QN327L) | |||||||||||||
| GELATIN, UNSPECIFIED(2G86QN327L) | |||||||||||||
| ISOPROPYL ALCOHOL(ND2M416302) | |||||||||||||
| MAGNESIUM STEARATE(70097M6I30) | |||||||||||||
| PROPYLENE GLYCOL(6DC9Q167V3) | |||||||||||||
| SHELLAC(46N107B71O) | |||||||||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | |||||||||||||
| SODIUM LAURYL SULFATE(368GB5141J) | |||||||||||||
| SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2) | |||||||||||||
| TITANIUM DIOXIDE(15FIX9V2JP) |
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