APPLICATION
ANDA074450
TYPE
ANDA
ORIGINAL APPROVAL
1996-05-16
LATEST ACTION
2015-04-29
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
2015-04-29Labeling · Supplement 14 · standardAP
2002-04-19Manufacturing (CMC) · Supplement 13AP
2001-11-06Manufacturing (CMC) · Supplement 12AP
2000-11-30Manufacturing (CMC) · Supplement 11AP
2000-09-18Manufacturing (CMC) · Supplement 10AP
2000-03-16Manufacturing (CMC) · Supplement 9AP
1999-09-07Labeling · Supplement 7AP
1999-09-07Manufacturing (CMC) · Supplement 8AP
1999-09-07Manufacturing (CMC) · Supplement 4AP
1999-05-07Manufacturing (CMC) · Supplement 5AP
1999-05-07Manufacturing (CMC) · Supplement 3AP
1998-06-22Manufacturing (CMC) · Supplement 2AP
1996-08-20Labeling · Supplement 1AP
1996-05-16OriginalAP
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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