Application 206505
- Type
- ANDA
- Sponsor
- NOVITIUM PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DAPSONE | DAPSONE | TABLET;ORAL | 25MG | No | No |
| 002 | DAPSONE | DAPSONE | TABLET;ORAL | 100MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0904-7018 | DAPSONE | Dapsone | Major Pharmaceuticals | ANDA | Current |
| 0904-7019 | DAPSONE | Dapsone | Major Pharmaceuticals | ANDA | Current |
| 10135-654 | DAPSONE | Dapsone | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-655 | DAPSONE | Dapsone | Marlex Pharmaceuticals Inc | ANDA | Current |
| 70954-135 | DAPSONE | Dapsone | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 70954-135 | DAPSONE | Dapsone | Novitium Pharma LLC | ANDA | Current |
| 70954-136 | DAPSONE | Dapsone | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 70954-136 | DAPSONE | Dapsone | Novitium Pharma LLC | ANDA | Current |