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USFDA APPLICATION NUMBER - 21656 / DOSAGE - TABLET;ORAL - 48MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| FENOFIBRATE(UNII: U202363UOS) (FENOFIBRATE - UNII:U202363UOS) | FENOFIBRATE | 145mg |
Inactive Ingredients
| Ingredient Name | Avera McKennan Hospital | Bryant Ranch Prepack | Cardinal Health | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | Lake Erie Medical DBA Quality Care Products LLC | NuCare Pharmaceuticals, Inc. | Teva Pharmaceuticals USA Inc | Zydus Pharmaceuticals USA Inc | A-S Medication Solutions | Unit Dose Services | A-S Medication Solutions LLC |
|---|---|---|---|---|---|---|---|---|---|---|---|
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | |||||||||||
| CROSPOVIDONE (120 .MU.M)(68401960MK) | |||||||||||
| CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK) | |||||||||||
| CROSPOVIDONE(2S7830E561) | |||||||||||
| CROSPOVIDONE(68401960MK) | |||||||||||
| D&C YELLOW NO. 10(35SW5USQ3G) | |||||||||||
| DOCUSATE SODIUM(F05Q2T2JA0) | |||||||||||
| FD&C BLUE NO. 2(L06K8R7DQK) | |||||||||||
| FD&C YELLOW NO. 6(H77VEI93A8) | |||||||||||
| HYPROMELLOSE 2910 (3 CPS)(0VUT3PMY82) | |||||||||||
| HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82) | |||||||||||
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | |||||||||||
| HYPROMELLOSES(3NXW29V3WO) | |||||||||||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | |||||||||||
| LECITHIN, SOYBEAN(1DI56QDM62) | |||||||||||
| MAGNESIUM STEARATE(70097M6I30) | |||||||||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |||||||||||
| POLYVINYL ALCOHOL(532B59J990) | |||||||||||
| POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990) | |||||||||||
| SODIUM LAURYL SULFATE(368GB5141J) | |||||||||||
| SUCROSE(C151H8M554) | |||||||||||
| TALC(7SEV7J4R1U) | |||||||||||
| TITANIUM DIOXIDE(15FIX9V2JP) | |||||||||||
| XANTHAN GUM(TTV12P4NEE) |
