APPLICATION
ANDA215876
TYPE
ANDA
ORIGINAL APPROVAL
2023-02-27
LATEST ACTION
2023-02-27
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
MEXILETINE HYDROCHLORIDEPrescription
MEXILETINE HYDROCHLORIDE 200MG · CAPSULE · ORAL
MEXILETINE HYDROCHLORIDEPrescription
MEXILETINE HYDROCHLORIDE 250MG · CAPSULE · ORAL
MEXILETINE HYDROCHLORIDEPrescription
MEXILETINE HYDROCHLORIDE 150MG · CAPSULE · ORAL
Approval history
2023-02-27UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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