APPLICATION
ANDA087361
TYPE
ANDA
ORIGINAL APPROVAL
1981-08-12
LATEST ACTION
1997-12-29
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
PRONESTYL-SRDiscontinued
PROCAINAMIDE HYDROCHLORIDE 500MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
1997-12-29Manufacturing (CMC) · Supplement 24AP
1993-11-09Manufacturing (CMC) · Supplement 23AP
1993-05-28Manufacturing (CMC) · Supplement 20AP
1991-09-17Labeling · Supplement 22AP
1991-05-02Labeling · Supplement 21AP
1990-02-26Bioequivalence · Supplement 19AP
1989-02-07Labeling · Supplement 18AP
1988-12-27Labeling · Supplement 15AP
1988-12-01Labeling · Supplement 17AP
1988-08-12Labeling · Supplement 16AP
1988-02-19Labeling · Supplement 14AP
1987-07-22Manufacturing (CMC) · Supplement 12AP
1987-07-22Manufacturing (CMC) · Supplement 11AP
1986-05-12Manufacturing (CMC) · Supplement 9AP
1985-07-17Manufacturing (CMC) · Supplement 7AP
1985-05-15Manufacturing (CMC) · Supplement 6AP
1984-06-18Manufacturing (CMC) · Supplement 4AP
1982-11-15Manufacturing (CMC) · Supplement 2AP
1981-08-12OriginalAP
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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