APPLICATION
NDA016647
TYPE
NDA
ORIGINAL APPROVAL
1969-12-08
LATEST ACTION
2001-04-26
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
QUINAGLUTE · ReferenceDiscontinued
QUINIDINE GLUCONATE 324MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
Approval history
2001-04-26Manufacturing (CMC) · Supplement 39 · standardAP
2000-11-14Manufacturing (CMC) · Supplement 38 · standardAP
2000-06-24Labeling · Supplement 36 · standardAP
1999-03-31Manufacturing (CMC) · Supplement 37 · standardAP
1998-07-01Labeling · Supplement 35 · standardAP
1995-11-16Manufacturing (CMC) · Supplement 34 · standardAP
1995-08-17Labeling · Supplement 33 · standardAP
1989-04-14Labeling · Supplement 29 · standardAP
1987-06-30Manufacturing (CMC) · Supplement 31 · standardAP
1987-04-14Manufacturing (CMC) · Supplement 30 · standardAP
1986-07-14Manufacturing (CMC) · Supplement 28 · standardAP
1985-07-30Manufacturing (CMC) · Supplement 27 · standardAP
1984-04-02Manufacturing (CMC) · Supplement 25 · standardAP
1984-01-23Manufacturing (CMC) · Supplement 23 · standardAP
1984-01-23Manufacturing (CMC) · Supplement 24 · standardAP
1984-01-23Manufacturing (CMC) · Supplement 22 · standardAP
1982-04-07Manufacturing (CMC) · Supplement 21 · standardAP
1981-04-07Manufacturing (CMC) · Supplement 19 · standardAP
1981-04-07Manufacturing (CMC) · Supplement 20 · standardAP
1981-02-25Manufacturing (CMC) · Supplement 17 · standardAP
1980-08-27Manufacturing (CMC) · Supplement 15 · standardAP
1979-09-25Manufacturing (CMC) · Supplement 11 · standardAP
1979-08-27Manufacturing (CMC) · Supplement 13 · standardAP
1979-08-27Manufacturing (CMC) · Supplement 14 · standardAP
1979-07-24Manufacturing (CMC) · Supplement 12 · standardAP
1978-07-25Manufacturing (CMC) · Supplement 9 · standardAP
1978-06-02Manufacturing (CMC) · Supplement 10 · standardAP
1977-10-06Manufacturing (CMC) · Supplement 8 · standardAP
1977-10-06Manufacturing (CMC) · Supplement 6 · standardAP
1977-10-06REMS · Supplement 4 · standardAP
1977-10-06Labeling · Supplement 5 · standardAP
1969-12-08Type 3 - New Dosage Form · 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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