| Active ingredient (INN) | Dantrolene Sodium |
|---|---|
| Brand names | Revonto |
| ATC level 5 | M03CA01 |
| ATC level 4 | M03CA |
|---|
| Therapeutic category | Auto-created by FDA Drug Enforcement — Full Recall Database scraper |
|---|
| Controlled substance | No |
|---|
| Marketing-authorisation holders | Amneal Pharmaceuticals of New York LLC, Pfizer Australia Pty Ltd, HIKMA CANADA LIMITED |
|---|
| Registrations on file | 7 |
|---|
| Patient information leaflet (PIL) | Not on file |
|---|
| Summary of product characteristics (SPC) | Not on file |
|---|
| Product | Strength | Form | Market | MA holder | Status |
|---|---|---|---|---|---|
| Dantrolene Sodium | 25mg/1 | capsule | 🇺🇸 US | Amneal Pharmaceuticals of New York LLC | Active |
| Dantrolene Sodium | 50mg/1 | capsule | 🇺🇸 US | Amneal Pharmaceuticals of New York LLC | Active |
| Dantrolene Sodium | 100mg/1 | capsule | 🇺🇸 US | Amneal Pharmaceuticals of New York LLC | Active |
| DANTRIUM dantrolene sodium hemiheptahydrate | 20mg | — | 🇦🇺 AU | Pfizer Australia Pty Ltd | Active |
| DANTRIUM dantrolene sodium hemiheptahydrate | 25mg | — | 🇦🇺 AU | Pfizer Australia Pty Ltd | Active |
| DANTRIUM dantrolene sodium hemiheptahydrate | 50mg | — | 🇦🇺 AU | Pfizer Australia Pty Ltd | Active |
| Dantrolene Sodium For Injection, Usp | — | solution | 🇨🇦 CA | HIKMA CANADA LIMITED | Active |