APPLICATION
ANDA087810
TYPE
ANDA
ORIGINAL APPROVAL
1982-09-29
LATEST ACTION
2001-01-08
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
QUINIDINE GLUCONATEDiscontinued
QUINIDINE GLUCONATE 324MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2001-01-08Labeling · Supplement 21AP
1999-04-30Labeling · Supplement 20AP
1998-10-08Manufacturing (CMC) · Supplement 18AP
1996-07-16Labeling · Supplement 17AP
1992-04-14Labeling · Supplement 13AP
1992-01-10Labeling · Supplement 12AP
1991-08-12Manufacturing (CMC) · Supplement 10AP
1991-08-07Manufacturing (CMC) · Supplement 8AP
1991-07-02Labeling · Supplement 11AP
1991-01-28Manufacturing (CMC) · Supplement 9AP
1988-03-18Manufacturing (CMC) · Supplement 5AP
1988-03-17Manufacturing (CMC) · Supplement 6AP
1983-11-08Manufacturing (CMC) · Supplement 2AP
1982-11-01Manufacturing (CMC) · Supplement 1AP
1982-09-29OriginalAP
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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