APPLICATION
NDA012796
TYPE
NDA
ORIGINAL APPROVAL
1962-02-21
LATEST ACTION
2007-12-07
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
QUINIDEXDiscontinued
QUINIDINE SULFATE 300MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2007-12-07Labeling · Supplement 8AP
2007-12-07Labeling · Supplement 24AP
2007-12-07Labeling · Supplement 29AP
1998-06-24Labeling · Supplement 48 · standardAP
1998-01-13Manufacturing (CMC) · Supplement 47 · priorityAP
1995-11-09Labeling · Supplement 46 · standardAP
1988-08-02Labeling · Supplement 38AP
1988-05-02Manufacturing (CMC) · Supplement 44 · priorityAP
1988-02-25Manufacturing (CMC) · Supplement 43 · priorityAP
1987-12-01Labeling · Supplement 42AP
1987-06-12Labeling · Supplement 41AP
1986-08-12Manufacturing (CMC) · Supplement 39 · priorityAP
1986-04-22Manufacturing (CMC) · Supplement 40 · priorityAP
1985-07-22Manufacturing (CMC) · Supplement 37 · priorityAP
1985-07-22Manufacturing (CMC) · Supplement 35 · priorityAP
1985-03-07Labeling · Supplement 36AP
1984-06-07Manufacturing (CMC) · Supplement 34 · priorityAP
1984-05-31Manufacturing (CMC) · Supplement 33 · priorityAP
1984-02-22Manufacturing (CMC) · Supplement 21 · priorityAP
1984-01-04Manufacturing (CMC) · Supplement 32 · priorityAP
1984-01-04Manufacturing (CMC) · Supplement 30 · priorityAP
1984-01-04Manufacturing (CMC) · Supplement 31 · priorityAP
1982-10-26Manufacturing (CMC) · Supplement 28 · priorityAP
1982-03-08Manufacturing (CMC) · Supplement 27 · priorityAP
1981-12-04Manufacturing (CMC) · Supplement 22 · priorityAP
1981-12-04Manufacturing (CMC) · Supplement 23 · priorityAP
1980-12-19Manufacturing (CMC) · Supplement 20 · priorityAP
1980-12-19Manufacturing (CMC) · Supplement 19 · priorityAP
1980-12-19Manufacturing (CMC) · Supplement 17 · priorityAP
1979-06-21Labeling · Supplement 18AP
1978-11-07Manufacturing (CMC) · Supplement 16 · priorityAP
1978-07-20Manufacturing (CMC) · Supplement 15 · priorityAP
1977-10-11Manufacturing (CMC) · Supplement 14 · priorityAP
1977-10-11Manufacturing (CMC) · Supplement 12 · priorityAP
1977-10-11Manufacturing (CMC) · Supplement 10 · priorityAP
1977-10-11Manufacturing (CMC) · Supplement 13 · priorityAP
1977-10-11Efficacy · Supplement 11AP
1962-02-21Type 3 - New Dosage Form · 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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