Application 086842
- Type
- ANDA
- Sponsor
- JACOBUS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DAPSONE | DAPSONE | TABLET;ORAL | 100MG | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 13925-505 | Dapsone | Dapsone | Seton Pharmaceuticals | ANDA | Current |
| 13925-505 | Dapsone | Dapsone | Seton Pharmaceuticals | ANDA | Current |
| 49938-101 | Dapsone | Dapsone | Jacobus Pharmaceutical Company, Inc. | ANDA | Current |
| 49938-101 | Dapsone | Dapsone | Jacobus Pharmaceutical Company, Inc. | ANDA | Current |
| 49938-101 | Dapsone | Dapsone | Jacobus Pharmaceutical Company, Inc. | ANDA | Current |
| 49938-101 | Dapsone | Dapsone | Jacobus Pharmaceutical Company, Inc. | ANDA | Current |
| 55695-025 | Dapsone | Dapsone | Department of State Health Services, Pharmacy Branch | ANDA | Current |