← FDA Drug Approvals (Drugs@FDA)
SOTALOL HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: REGCON HOLDINGS · Approved 2018-11-02
Drug application
- FDA Application #
ANDA207429- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- SOTALOL HYDROCHLORIDE
- Generic name
- SOTALOL HYDROCHLORIDE TABLES AF
- Active ingredients
- SOTALOL HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- REGCON HOLDINGS
- Manufacturer
- UNICHEM PHARMACEUTICALS (USA), INC.
- First approval
- 2018-11-02
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown