
USFDA APPLICATION NUMBER - 13217 / DOSAGE - TABLET;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 |
|---|---|---|
| Metaxalone(UNII: 1NMA9J598Y) (Metaxalone - UNII:1NMA9J598Y) | Metaxalone | 800mg |
Inactive Ingredients
| Ingredient Name | A-S Medication Solutions | Bryant Ranch Prepack | Cardinal Health | CorePharma, LLC | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | Lake Erie Medical DBA Quality Care Products LLC | PD-Rx Pharmaceuticals, Inc. | Preferred Pharmaceuticals, Inc. | REMEDYREPACK INC. | Unit Dose Services | REMEDYREPACK INC. |
|---|---|---|---|---|---|---|---|---|---|---|---|
| ALGINIC ACID(8C3Z4148WZ) | |||||||||||
| CALCIUM ALGINATE(8P20S56HZI) | |||||||||||
| CALCIUM(SY7Q814VUP) | |||||||||||
| CARMINIC ACID(CID8Z8N95N) | |||||||||||
| MAGNESIUM STEARATE (70097M6I30) | |||||||||||
| MAGNESIUM STEARATE(70097M6I30) | |||||||||||
| STARCH, CORN (O8232NY3SJ) | |||||||||||
| STARCH, CORN(O8232NY3SJ) |