APPLICATION
NDA017371
TYPE
NDA
ORIGINAL APPROVAL
1974-02-28
LATEST ACTION
2009-03-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PRONESTYLDiscontinued
PROCAINAMIDE HYDROCHLORIDE 375MG · TABLET · ORAL
PRONESTYLDiscontinued
PROCAINAMIDE HYDROCHLORIDE 500MG · TABLET · ORAL
PRONESTYLDiscontinued
PROCAINAMIDE HYDROCHLORIDE 250MG · TABLET · ORAL
Approval history
2009-03-13Efficacy · Supplement 9AP
1997-05-06Labeling · Supplement 31 · standardAP
1995-09-06Manufacturing (CMC) · Supplement 30 · standardAP
1992-03-17Manufacturing (CMC) · Supplement 29 · standardAP
1991-10-03Efficacy · Supplement 28AP
1989-03-30Labeling · Supplement 27AP
1987-02-20Manufacturing (CMC) · Supplement 26 · standardAP
1986-09-23Manufacturing (CMC) · Supplement 25 · standardAP
1985-08-01Manufacturing (CMC) · Supplement 24 · standardAP
1985-05-30Manufacturing (CMC) · Supplement 23 · standardAP
1985-05-08Labeling · Supplement 17AP
1984-05-31Manufacturing (CMC) · Supplement 22 · standardAP
1983-09-15Manufacturing (CMC) · Supplement 21 · standardAP
1983-01-13Manufacturing (CMC) · Supplement 20 · standardAP
1983-01-13Manufacturing (CMC) · Supplement 19 · standardAP
1981-03-19Manufacturing (CMC) · Supplement 18 · standardAP
1979-08-27Manufacturing (CMC) · Supplement 16 · standardAP
1979-01-25Manufacturing (CMC) · Supplement 15 · standardAP
1978-08-28Manufacturing (CMC) · Supplement 13 · standardAP
1978-08-28Manufacturing (CMC) · Supplement 14 · standardAP
1978-04-27Manufacturing (CMC) · Supplement 11 · standardAP
1978-04-27Manufacturing (CMC) · Supplement 12 · standardAP
1977-03-08Labeling · Supplement 10AP
1976-04-02Labeling · Supplement 8AP
1975-05-13Manufacturing (CMC) · Supplement 7 · standardAP
1974-02-28Type 3 - New Dosage Form · Original · standardAP
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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