APPLICATION
ANDA089438
TYPE
ANDA
ORIGINAL APPROVAL
1987-03-23
LATEST ACTION
2002-12-09
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
PROCAINAMIDE HYDROCHLORIDEDiscontinued
PROCAINAMIDE HYDROCHLORIDE 750MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2002-12-09Manufacturing (CMC) · Supplement 15AP
2002-12-09Manufacturing (CMC) · Supplement 16AP
2002-12-09Manufacturing (CMC) · Supplement 14AP
2002-03-13Labeling · Supplement 18AP
2002-01-04Labeling · Supplement 17AP
2001-04-02Manufacturing (CMC) · Supplement 13AP
1999-06-17Manufacturing (CMC) · Supplement 12AP
1999-03-23Manufacturing (CMC) · Supplement 11AP
1998-06-11Manufacturing (CMC) · Supplement 10AP
1996-05-31Manufacturing (CMC) · Supplement 9AP
1995-06-23Labeling · Supplement 8AP
1993-06-25Manufacturing (CMC) · Supplement 7AP
1991-12-30Labeling · Supplement 6AP
1991-12-30Labeling · Supplement 4AP
1991-11-13Labeling · Supplement 5AP
1991-02-22Manufacturing (CMC) · Supplement 3AP
1991-02-22Labeling · Supplement 2AP
1989-04-06Labeling · Supplement 1AP
1987-03-23OriginalAP
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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