FdaApplication
ANDA 219987
Identifiers
- fda_app_no: ANDA219987
Properties
| Property | Value |
|---|---|
| applicant_name | MACLEODS PHARMACEUTICALS LTD |
| application_type | ANDA |
| approval_date | 2026-03-23 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | 250MG | CAPSULE;ORAL |
| MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | 150MG | CAPSULE;ORAL |
| MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | 200MG | CAPSULE;ORAL |
3 products