← FDA Drug Approvals (Drugs@FDA)
MEXILETINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: INGENUS PHARMS LLC · Approved 2021-01-25
Drug application
- FDA Application #
ANDA214352- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- MEXILETINE HYDROCHLORIDE
- Generic name
- MEXILETINE HYDROCHLORIDE
- Active ingredients
- MEXILETINE HYDROCHLORIDE
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- INGENUS PHARMS LLC
- Manufacturer
- Ingenus Pharmaceuticals, LLC
- First approval
- 2021-01-25
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown