Ciprofloxacin and Fluocinolone Acetonide is a Auricular (otic) Solution in the Human Prescription Drug category. It is labeled and distributed by Wilshire Pharmaceuticals. The primary component is Ciprofloxacin; Fluocinolone Acetonide.
| Product ID | 52536-080_902d710e-3983-4f9b-b8eb-4a990bc4efa8 |
| NDC | 52536-080 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Ciprofloxacin and Fluocinolone Acetonide |
| Generic Name | Ciprofloxacin And Fluocinolone Acetonide |
| Dosage Form | Solution |
| Route of Administration | AURICULAR (OTIC) |
| Marketing Start Date | 2019-11-01 |
| Marketing Category | NDA / NDA |
| Application Number | NDA208251 |
| Labeler Name | Wilshire Pharmaceuticals |
| Substance Name | CIPROFLOXACIN; FLUOCINOLONE ACETONIDE |
| Active Ingredient Strength | 1 mg/.25mL; mg/.25mL |
| Pharm Classes | Quinolone Antimicrobial [EPC],Quinolones [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2019-11-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA |
| Application Number | NDA208251 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-11-01 |
| Ingredient | Strength |
|---|---|
| CIPROFLOXACIN | .75 mg/.25mL |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 42195-128 | Ciprofloxacin and Fluocinolone Acetonide | ciprofloxacin and fluocinolone acetonide |
| 52536-080 | Ciprofloxacin and Fluocinolone Acetonide | ciprofloxacin and fluocinolone acetonide |
| 66992-128 | OTOVEL | ciprofloxacin and fluocinolone acetonide |