Application 019356
- Type
- NDA
- Sponsor
- SEBELA IRELAND LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NAFTIN | NAFTIFINE HYDROCHLORIDE | GEL;TOPICAL | 1% | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 54766-770 | Naftin | NAFTIFINE HYDROCHLORIDE | Sebela Pharmaceuticals Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 53994 | SUPPL | 2018-05-03 |
| 53981 | SUPPL | 2018-05-02 |
| 1291 | SUPPL | 2007-10-04 |