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USFDA APPLICATION NUMBER - 21612 / DOSAGE - CAPSULE;ORAL - 50MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| FENOFIBRATE(UNII: U202363UOS) (FENOFIBRATE - UNII:U202363UOS) | FENOFIBRATE | 150mg | 50mg |
Inactive Ingredients
| Ingredient Name | H2-Pharma, LLC | Kowa Pharmaceuticals America, Inc. |
|---|---|---|
| D&C YELLOW NO. 10(35SW5USQ3G) | ||
| FD&C BLUE NO. 1(H3R47K3TBD) | ||
| FD&C BLUE NO. 2(L06K8R7DQK) | ||
| FD&C RED NO. 40(WZB9127XOA) | ||
| FERROSOFERRIC OXIDE(XM0M87F357) | ||
| GELATIN(2G86QN327L) | ||
| GELATIN, UNSPECIFIED(2G86QN327L) | ||
| HYDROXYPROPYL CELLULOSE (160000 WAMW)(0A7M0N7SPE) | ||
| HYDROXYPROPYL CELLULOSE(RFW2ET671P) | ||
| LAUROYL PEG-32 GLYCERIDES(H5ZC52369M) | ||
| POLYETHYLENE GLYCOL 20000(5WKN5KL2O8) | ||
| POLYETHYLENE GLYCOL 8000(Q662QK8M3B) | ||
| PROPYLENE GLYCOL(6DC9Q167V3) | ||
| SHELLAC(46N107B71O) | ||
| SODIUM STARCH GLYCOLATE TYPE A(H8AV0SQX4D) | ||
| TITANIUM DIOXIDE(15FIX9V2JP) |
