APPLICATION
ANDA089839
TYPE
ANDA
ORIGINAL APPROVAL
1988-09-29
LATEST ACTION
2025-07-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
QUINIDINE SULFATEDiscontinued
QUINIDINE SULFATE 300MG · TABLET · ORAL
Approval history
2025-07-29Labeling · Supplement 7 · standardAP
1996-06-10Labeling · Supplement 6AP
1995-04-26Manufacturing (CMC) · Supplement 5AP
1989-06-26Bioequivalence · Supplement 4AP
1989-03-24Labeling · Supplement 3AP
1988-12-20Labeling · Supplement 1AP
1988-09-29OriginalAP
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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