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FDA ANDA · ANDA084914

QUINIDINE SULFATE

Sponsor: SANDOZ

APPLICATION
ANDA084914
TYPE
ANDA
ORIGINAL APPROVAL
1977-08-18
LATEST ACTION
1996-06-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

QUINIDINE SULFATEDiscontinued
QUINIDINE SULFATE 200MG · TABLET · ORAL

Approval history

1996-06-10Labeling · Supplement 30AP
1995-04-26Manufacturing (CMC) · Supplement 29AP
1989-03-24Labeling · Supplement 28AP
1988-12-20Labeling · Supplement 27AP
1988-12-20Labeling · Supplement 31AP
1985-03-12Manufacturing (CMC) · Supplement 25AP
1984-06-01Manufacturing (CMC) · Supplement 23AP
1984-06-01Manufacturing (CMC) · Supplement 24AP
1983-11-08Manufacturing (CMC) · Supplement 22AP
1983-07-22Manufacturing (CMC) · Supplement 21AP
1982-09-30Manufacturing (CMC) · Supplement 20AP
1982-03-10Manufacturing (CMC) · Supplement 12AP
1982-03-10Manufacturing (CMC) · Supplement 19AP
1982-03-10Manufacturing (CMC) · Supplement 15AP
1982-03-10Manufacturing (CMC) · Supplement 13AP
1982-03-10Manufacturing (CMC) · Supplement 16AP
1982-03-10Manufacturing (CMC) · Supplement 14AP
1977-08-18OriginalAP
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