Composition
- Active ingredients
- SOTALOL HYDROCHLORIDE 80MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- SOTALOL HYDROCHLORIDE 40MG · TabletNDA021151-006 · Discontinued
- SOTALOL HYDROCHLORIDE 120MG · TabletNDA021151-002 · Prescription
- SOTALOL HYDROCHLORIDE 60MG · TabletNDA021151-007 · Discontinued
- SOTALOL HYDROCHLORIDE 100MG · TabletNDA021151-005 · Discontinued
- SOTALOL HYDROCHLORIDE 160MG · TabletNDA021151-003 · Prescription
- SOTALOL HYDROCHLORIDE 80MG · TabletThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA021151.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Betapace Af
- Active substance
- sotalol hydrochloride
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Legacy Pharma
- Status
- Prescription
- FDA approval
- 22 Feb 2000
- Application
- NDA021151-001