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USFDA APPLICATION NUMBER - 20634 / DOSAGE - TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 |
|---|---|---|
| LEVOFLOXACIN(UNII: 6GNT3Y5LMF) (LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14) | LEVOFLOXACIN ANHYDROUS | 500mg |
Inactive Ingredients
| Ingredient Name | A-S Medication Solutions | Lake Erie Medical DBA Quality Care Products LLC | PD-Rx Pharmaceuticals, Inc. | Physicians Total Care, Inc. | Rebel Distributors Corp | RedPharm Drug Inc. | REMEDYREPACK INC. | Bryant Ranch Prepack | Cardinal Health | Janssen Pharmaceuticals, Inc. |
|---|---|---|---|---|---|---|---|---|---|---|
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | ||||||||||
| crospovidone (15 mpa.s at 5%)(68401960MK) | ||||||||||
| crospovidone(68401960MK) | ||||||||||
| ferric oxide red(1K09F3G675) | ||||||||||
| FERRIC OXIDE YELLOW(EX438O2MRT) | ||||||||||
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | ||||||||||
| hypromelloses(3NXW29V3WO) | ||||||||||
| magnesium stearate(70097M6I30) | ||||||||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||||||||||
| POLYETHYLENE GLYCOL 400(B697894SGQ) | ||||||||||
| polyethylene glycol(3WJQ0SDW1A) | ||||||||||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | ||||||||||
| polyethylene glycols(3WJQ0SDW1A) | ||||||||||
| polysorbate 80(6OZP39ZG8H) | ||||||||||
| titanium dioxide(15FIX9V2JP) |
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