| NDC Code | 24338-080-14 |
| Package Description | 1 POUCH in 1 CARTON (24338-080-14) > 14 VIAL, SINGLE-DOSE in 1 POUCH > .25 mL in 1 VIAL, SINGLE-DOSE (24338-080-25) |
| Product NDC | 24338-080 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Otovel |
| Non-Proprietary Name | (ciprofloxacin And Fluocinolone Acetonide) |
| Dosage Form | SOLUTION |
| Usage | AURICULAR (OTIC) |
| Start Marketing Date | 20160429 |
| Marketing Category Name | NDA |
| Application Number | NDA208251 |
| Manufacturer | Arbor Pharmaceuticals |
| Substance Name | CIPROFLOXACIN; FLUOCINOLONE ACETONIDE |
| Strength | .75; .0625 |
| Strength Unit | mg/.25mL; mg/.25mL |
| Pharmacy Classes | Quinolone Antimicrobial [EPC],Quinolones [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |