APPLICATION
ANDA089894
TYPE
ANDA
ORIGINAL APPROVAL
1988-12-15
LATEST ACTION
2001-05-09
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
QUINIDINE GLUCONATEDiscontinued
QUINIDINE GLUCONATE 324MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2001-05-09Manufacturing (CMC) · Supplement 8AP
1999-06-29Manufacturing (CMC) · Supplement 6AP
1999-06-29Labeling · Supplement 7AP
1997-11-20Labeling · Supplement 5AP
1995-04-06Manufacturing (CMC) · Supplement 4AP
1992-11-02Labeling · Supplement 3AP
1988-12-15OriginalAP
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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