← FDA Drug Approvals (Drugs@FDA)
MEXILETINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: CROSSMEDIKA SA · Approved 2020-07-22
Drug application
- FDA Application #
ANDA213500- 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
- CROSSMEDIKA SA
- Manufacturer
- Chartwell RX, LLC
- First approval
- 2020-07-22
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown