FdaApplication
ANDA 076686
Identifiers
- fda_app_no: ANDA076686
Properties
| Property | Value |
|---|---|
| applicant_name | ELITE LABORATORIES INC |
| application_type | ANDA |
| approval_date | 2005-10-24 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DANTROLENE SODIUM | DANTROLENE SODIUM | 25MG | CAPSULE;ORAL |
| DANTROLENE SODIUM | DANTROLENE SODIUM | 100MG | CAPSULE;ORAL |
| DANTROLENE SODIUM | DANTROLENE SODIUM | 50MG | CAPSULE;ORAL |
3 products