# SOTALOL HYDROCHLORIDE
> **ANDA207428** · Abbreviated New Drug Application (Generic) · Sponsor: REGCON HOLDINGS · Approved 2016-10-21
## Drug
- **FDA Application Number:** ANDA207428
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** SOTALOL HYDROCHLORIDE
- **Generic name:** SOTALOL HYDROCHLORIDE
- **Active ingredients:** SOTALOL HYDROCHLORIDE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** REGCON HOLDINGS
- **Manufacturer:** UNICHEM PHARMACEUTICALS (USA), INC.
- **First approval:** 2016-10-21
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207428)
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