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FDA ANDA · ANDA040045

QUINIDINE SULFATE

Sponsor: COSETTE PHARMS NC

APPLICATION
ANDA040045
TYPE
ANDA
ORIGINAL APPROVAL
1994-06-30
LATEST ACTION
2003-10-03
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

QUINIDINE SULFATEDiscontinued
QUINIDINE SULFATE 300MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2003-10-03Labeling · Supplement 16AP
2002-01-23Manufacturing (CMC) · Supplement 8AP
2001-10-31Manufacturing (CMC) · Supplement 11AP
2001-10-31Manufacturing (CMC) · Supplement 9AP
2001-10-31Manufacturing (CMC) · Supplement 10AP
1999-07-15Manufacturing (CMC) · Supplement 5AP
1999-05-26Labeling · Supplement 7AP
1999-03-23Manufacturing (CMC) · Supplement 6AP
1996-07-26Labeling · Supplement 3AP
1996-05-31Manufacturing (CMC) · Supplement 2AP
1996-03-19Manufacturing (CMC) · Supplement 1AP
1994-06-30OriginalAP
VIEW ON DRUGS@FDA ↗

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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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