← FDA Drug Approvals (Drugs@FDA)
SOTYLIZE
NDA · New Drug Application · Sponsor: AZURITY · Approved 2014-10-22
Drug application
- FDA Application #
NDA205108
- Application type
- New Drug Application
- Brand name
- SOTYLIZE
- Generic name
- SOTALOL HYDROCHLORIDE
- Active ingredients
- SOTALOL HYDROCHLORIDE
- Dosage form
- SOLUTION
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- AZURITY
- Manufacturer
- Azurity Pharmaceuticals, Inc.
- First approval
- 2014-10-22
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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