Skip to contentApplication 076686
- Type
- ANDA
- Sponsor
- ELITE LABS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DANTROLENE SODIUM | DANTROLENE SODIUM | CAPSULE;ORAL | 25MG | No | No |
| 002 | DANTROLENE SODIUM | DANTROLENE SODIUM | CAPSULE;ORAL | 50MG | No | No |
| 003 | DANTROLENE SODIUM | DANTROLENE SODIUM | CAPSULE;ORAL | 100MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0527-3219 | Dantrolene Sodium | dantrolene sodium | Lannett Company, Inc. | ANDA | Current |
| 0527-3220 | Dantrolene Sodium | dantrolene sodium | Lannett Company, Inc. | ANDA | Current |
| 0527-3221 | Dantrolene Sodium | dantrolene sodium | Lannett Company, Inc. | ANDA | Current |
| 64850-840 | Dantrolene Sodium | dantrolene sodium | Elite Laboratories, Inc. | ANDA | Current |
| 64850-841 | Dantrolene Sodium | dantrolene sodium | Elite Laboratories, Inc. | ANDA | Current |
| 64850-842 | Dantrolene Sodium | dantrolene sodium | Elite Laboratories, Inc. | ANDA | Current |