FDA
Dantrolene Sodium
The FDA lists this product in 8 strengths and forms.
Composition
- Active ingredients
- DANTROLENE SODIUM 20MG/VIAL
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- DANTROLENE SODIUM 20MG/VIAL · InjectableANDA205239-001 · Discontinued
- DANTROLENE SODIUM 20MG/VIAL · InjectableThis page
- DANTROLENE SODIUM 50MG · CapsuleANDA076686-002 · Prescription
- DANTROLENE SODIUM 100MG · CapsuleANDA076686-003 · Prescription
- DANTROLENE SODIUM 25MG · CapsuleANDA076686-001 · Prescription
- DANTROLENE SODIUM 50MG · CapsuleANDA076856-002 · Prescription
- DANTROLENE SODIUM 100MG · CapsuleANDA076856-003 · Prescription
- DANTROLENE SODIUM 25MG · CapsuleANDA076856-001 · Prescription
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA204762.
At a glance
- Brand name
- Dantrolene Sodium
- Route
- Injection
- Dosage form
- Injectable
- Applicant
- Hikma
- Status
- Prescription
- FDA approval
- 19 Jun 2017
- Application
- ANDA204762-001