| NDC Code | 72641-002-20 |
| Package Description | 1 BOTTLE, DROPPER in 1 CARTON (72641-002-20) > 20 mL in 1 BOTTLE, DROPPER |
| Product NDC | 72641-002 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Fluocinolone Acetonide Oil, 0.01% (ear Drops) |
| Non-Proprietary Name | Fluocinolone Acetonide Oil, 0.01% (ear Drops) |
| Dosage Form | OIL |
| Usage | AURICULAR (OTIC) |
| Start Marketing Date | 20210205 |
| Marketing Category Name | ANDA |
| Application Number | ANDA213264 |
| Manufacturer | Tasman Pharma Inc. |
| Substance Name | FLUOCINOLONE ACETONIDE |
| Strength | .11 |
| Strength Unit | mg/mL |
| Pharmacy Classes | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |