← FDA Drug Approvals (Drugs@FDA)
FLECAINIDE ACETATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: REGCON HOLDINGS · Approved 2020-09-16
Drug application
- FDA Application #
ANDA210683- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- FLECAINIDE ACETATE
- Generic name
- FLECAINIDE ACETATE
- Active ingredients
- FLECAINIDE ACETATE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- REGCON HOLDINGS
- Manufacturer
- UNICHEM PHARMACEUTICALS (USA), INC.
- First approval
- 2020-09-16
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown