Application 019084
- Type
- NDA
- Sponsor
- JANSSEN PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NIZORAL | KETOCONAZOLE | CREAM;TOPICAL | 2% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 23547 | ORIG | 2014-02-07 |