APPLICATION
ANDA089338
TYPE
ANDA
ORIGINAL APPROVAL
1987-02-11
LATEST ACTION
2010-02-02
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
QUINIDINE GLUCONATEPrescription
QUINIDINE GLUCONATE 324MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2003-03-31Labeling · Supplement 24AP
2001-07-10Manufacturing (CMC) · Supplement 20AP
2001-06-04Manufacturing (CMC) · Supplement 16AP
2000-07-17Labeling · Supplement 17AP
2000-05-16Manufacturing (CMC) · Supplement 18AP
2000-05-16Manufacturing (CMC) · Supplement 19AP
1999-02-04Labeling · Supplement 15AP
1997-12-05Manufacturing (CMC) · Supplement 14AP
1997-02-24Manufacturing (CMC) · Supplement 13AP
1996-12-06Labeling · Supplement 12AP
1996-04-25Manufacturing (CMC) · Supplement 10AP
1995-07-31Manufacturing (CMC) · Supplement 9AP
1995-06-22Manufacturing (CMC) · Supplement 11AP
1994-01-12Manufacturing (CMC) · Supplement 8AP
1993-06-15Labeling · Supplement 7AP
1991-07-16Manufacturing (CMC) · Supplement 6AP
1990-03-08Labeling · Supplement 5AP
1990-01-12Labeling · Supplement 4AP
1987-07-17Manufacturing (CMC) · Supplement 3AP
1987-07-17Manufacturing (CMC) · Supplement 1AP
1987-02-11OriginalAP
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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