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USFDA APPLICATION NUMBER - 21085 / DOSAGE - TABLET;ORAL - EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 |
|---|---|---|
| MOXIFLOXACIN HYDROCHLORIDE(UNII: C53598599T) (MOXIFLOXACIN - UNII:U188XYD42P) | MOXIFLOXACIN | 400mg |
Inactive Ingredients
| Ingredient Name | Lake Erie Medical DBA Quality Care Products LLC | PD-Rx Pharmaceuticals, Inc. | REMEDYREPACK INC. | Schering Plough Corporation | Alvogen, Inc. | Bayer HealthCare Pharmaceuticals Inc. | Cardinal Health |
|---|---|---|---|---|---|---|---|
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | |||||||
| CROSCARMELLOSE SODIUM(M28OL1HH48) | |||||||
| FERRIC OXIDE RED(1K09F3G675) | |||||||
| HYDROCHLORIC ACID(QTT17582CB) | |||||||
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | |||||||
| HYPROMELLOSES(3NXW29V3WO) | |||||||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | |||||||
| MAGNESIUM STEARATE(70097M6I30) | |||||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |||||||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | |||||||
| POLYETHYLENE GLYCOLS(3WJQ0SDW1A) | |||||||
| SODIUM CHLORIDE(451W47IQ8X) | |||||||
| SODIUM HYDROXIDE(55X04QC32I) | |||||||
| TITANIUM DIOXIDE(15FIX9V2JP) | |||||||
| WATER(059QF0KO0R) |
