← FDA Drug Approvals (Drugs@FDA)
MEXILETINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MACLEODS PHARMS LTD · Approved 2026-03-23
Drug application
- FDA Application #
ANDA219987- 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
- MACLEODS PHARMS LTD
- Manufacturer
- Macleods Pharmaceuticals Limited
- First approval
- 2026-03-23
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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