Application 207154
- Type
- NDA
- Sponsor
- ALMIRALL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACZONE | DAPSONE | GEL;TOPICAL | 7.5% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0023-5206 | ACZONE | dapsone | Allergan, Inc. | NDA | Current |
| 0023-5206 | ACZONE | dapsone | Allergan, Inc. | NDA | Current |
| 0023-5206 | ACZONE | dapsone | Allergan, Inc. | NDA | Current |
| 16110-526 | Aczone | dapsone | Almirall, LLC | NDA | Current |
| 16110-526 | Aczone | dapsone | Almirall, LLC | NDA | Current |
| 16110-526 | Aczone | dapsone | Almirall, LLC | NDA | Current |
| 51672-5307 | Dapsone | Dapsone | Taro Pharmaceuticals U.S.A., Inc. | NDA AUTHORIZED GENERIC | Current |
| 51672-5307 | Dapsone | Dapsone | Taro Pharmaceuticals U.S.A., Inc. | NDA | Current |