Application 207421
- Type
- ANDA
- Sponsor
- ASCENT PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DRONABINOL | DRONABINOL | CAPSULE;ORAL | 2.5MG | No | No |
| 002 | DRONABINOL | DRONABINOL | CAPSULE;ORAL | 5MG | No | No |
| 003 | DRONABINOL | DRONABINOL | CAPSULE;ORAL | 10MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0527-4125 | DRONABINOL | dronabinol | Lannett Company, Inc. | ANDA | Current |
| 31722-960 | DRONABINOL | dronabinol | Camber Pharmaceuticals Inc | ANDA | Current |
| 31722-961 | DRONABINOL | dronabinol | Camber Pharmaceuticals Inc | ANDA | Current |
| 31722-962 | DRONABINOL | dronabinol | Camber Pharmaceuticals Inc | ANDA | Current |
| 42291-449 | DRONABINOL | dronabinol | AvKARE | ANDA | Current |
| 42291-450 | DRONABINOL | dronabinol | AvKARE | ANDA | Current |
| 42291-451 | DRONABINOL | dronabinol | AvKARE | ANDA | Current |