Application 204074
- Type
- ANDA
- Sponsor
- VIRTUS PHARMS
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 |
|---|---|---|---|---|---|
| 42291-298 | Dapsone | Dapsone | AvKARE, Inc. | ANDA | Current |
| 42291-299 | Dapsone | Dapsone | AvKARE, Inc. | ANDA | Current |
| 43353-222 | Dapsone | Dapsone | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-223 | Dapsone | Dapsone | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 69543-150 | Dapsone | Dapsone | Virtus Pharmaceuticals | ANDA | Current |
| 69543-150 | Dapsone | Dapsone | Virtus Pharmaceuticals | ANDA | Current |
| 69543-151 | Dapsone | Dapsone | Virtus Pharmaceuticals | ANDA | Current |
| 69543-151 | Dapsone | Dapsone | Virtus Pharmaceuticals | ANDA | Current |