APPLICATION
NDA018257
TYPE
NDA
ORIGINAL APPROVAL
1984-11-09
LATEST ACTION
2001-10-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TONOCARDDiscontinued
TOCAINIDE HYDROCHLORIDE 400MG · TABLET · ORAL
TONOCARDDiscontinued
TOCAINIDE HYDROCHLORIDE 600MG · TABLET · ORAL
Approval history
2001-10-24Labeling · Supplement 29 · priorityAP
2001-01-18Manufacturing (CMC) · Supplement 28 · priorityAP
2000-06-02Manufacturing (CMC) · Supplement 27 · priorityAP
1999-07-07Labeling · Supplement 26 · priorityAP
1997-11-10Manufacturing (CMC) · Supplement 24 · priorityAP
1997-10-27Manufacturing (CMC) · Supplement 25 · priorityAP
1995-11-28Labeling · Supplement 23 · priorityAP
1992-10-08Manufacturing (CMC) · Supplement 22 · priorityAP
1992-09-16Labeling · Supplement 20 · priorityAP
1989-12-07Manufacturing (CMC) · Supplement 18 · priorityAP
1989-07-10Labeling · Supplement 19 · priorityAP
1988-08-15Manufacturing (CMC) · Supplement 12 · priorityAP
1988-04-07Manufacturing (CMC) · Supplement 17 · priorityAP
1987-08-28Labeling · Supplement 14 · priorityAP
1987-07-07Manufacturing (CMC) · Supplement 16 · priorityAP
1987-06-01Manufacturing (CMC) · Supplement 15 · priorityAP
1987-01-21Manufacturing (CMC) · Supplement 13 · priorityAP
1986-04-17Labeling · Supplement 8 · priorityAP
1986-02-28Manufacturing (CMC) · Supplement 11 · priorityAP
1985-09-13Manufacturing (CMC) · Supplement 9 · priorityAP
1985-05-13Labeling · Supplement 7 · priorityAP
1985-05-13Labeling · Supplement 6 · priorityAP
1985-02-26Manufacturing (CMC) · Supplement 3 · priorityAP
1985-02-25Labeling · Supplement 1 · priorityAP
1985-02-25Labeling · Supplement 2 · priorityAP
1985-01-30Manufacturing (CMC) · Supplement 5 · priorityAP
1985-01-30Manufacturing (CMC) · Supplement 4 · priorityAP
1984-11-09Type 1 - New Molecular Entity · Original · 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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