APPLICATION
ANDA081031
TYPE
ANDA
ORIGINAL APPROVAL
1989-04-14
LATEST ACTION
2010-02-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
QUINIDINE SULFATEDiscontinued
QUINIDINE SULFATE 300MG · TABLET · ORAL
Approval history
2010-02-02Labeling · Supplement 24AP
2001-05-16Manufacturing (CMC) · Supplement 9AP
2000-05-16Manufacturing (CMC) · Supplement 7AP
2000-05-16Manufacturing (CMC) · Supplement 8AP
1999-01-28Labeling · Supplement 6AP
1997-12-05Manufacturing (CMC) · Supplement 5AP
1997-02-24Manufacturing (CMC) · Supplement 4AP
1996-03-25Labeling · Supplement 3AP
1995-06-22Manufacturing (CMC) · Supplement 2AP
1994-01-12Manufacturing (CMC) · Supplement 1AP
1989-04-14OriginalAP
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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