APPLICATION
NDA018873
TYPE
NDA
ORIGINAL APPROVAL
1985-12-30
LATEST ACTION
2004-02-25
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
MEXITIL · ReferenceDiscontinued
MEXILETINE HYDROCHLORIDE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
MEXITIL · ReferenceDiscontinued
MEXILETINE HYDROCHLORIDE 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
MEXITIL · ReferenceDiscontinued
MEXILETINE HYDROCHLORIDE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
Approval history
2002-12-09Manufacturing (CMC) · Supplement 17 · priorityAP
1999-09-30Manufacturing (CMC) · Supplement 16 · priorityAP
1996-05-10Labeling · Supplement 15 · standardAP
1995-09-19Manufacturing (CMC) · Supplement 14 · priorityAP
1992-01-03Manufacturing (CMC) · Supplement 11 · priorityAP
1991-10-21Labeling · Supplement 10AP
1991-10-21Labeling · Supplement 9AP
1991-10-21Labeling · Supplement 7AP
1991-10-21Efficacy · Supplement 13AP
1991-08-13Manufacturing (CMC) · Supplement 12 · priorityAP
1989-03-22Manufacturing (CMC) · Supplement 8 · priorityAP
1988-12-22Manufacturing (CMC) · Supplement 6 · priorityAP
1988-06-03Labeling · Supplement 5AP
1987-12-10Labeling · Supplement 2AP
1987-09-10Manufacturing (CMC) · Supplement 4 · priorityAP
1987-05-05Manufacturing (CMC) · Supplement 3 · priorityAP
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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