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USFDA APPLICATION NUMBER - 19594 / DOSAGE - CAPSULE;ORAL - 300MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| URSODIOL(UNII: 724L30Y2QR) (URSODIOL - UNII:724L30Y2QR) | URSODIOL | 300mg |
Inactive Ingredients
| Ingredient Name | Major Pharmaceuticals | Golden State Medical Supply, Inc. | NCS HealthCare of KY, Inc dba Vangard Labs | Avera McKennan Hospital | AvKARE, Inc. | AvPAK | Cardinal Health 107, LLC | Mylan Institutional Inc. | Mylan Pharmaceuticals Inc. | A-S Medication Solutions | Preferred Pharmaceuticals Inc. | American Health Packaging | Cardinal Health |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ALCOHOL(3K9958V90M) | |||||||||||||
| ALUMINUM OXIDE(LMI26O6933) | |||||||||||||
| BUTYL ALCOHOL(8PJ61P6TS3) | |||||||||||||
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | |||||||||||||
| 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) | |||||||||||||
| FERRIC OXIDE(1K09F3G675) | |||||||||||||
| FERROSOFERRIC OXIDE(XM0M87F357) | |||||||||||||
| GELATIN(2G86QN327L) | |||||||||||||
| GELATIN, UNSPECIFIED(2G86QN327L) | |||||||||||||
| HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH) | |||||||||||||
| MAGNESIUM STEARATE(70097M6I30) | |||||||||||||
| METHYL ALCOHOL(Y4S76JWI15) | |||||||||||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |||||||||||||
| PROPYLENE GLYCOL(6DC9Q167V3) | |||||||||||||
| SHELLAC(46N107B71O) | |||||||||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | |||||||||||||
| SODIUM LAURYL SULFATE(368GB5141J) | |||||||||||||
| SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2) | |||||||||||||
| STARCH, CORN(O8232NY3SJ) | |||||||||||||
| TITANIUM DIOXIDE(15FIX9V2JP) |
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