APPLICATION
NDA007335
TYPE
NDA
ORIGINAL APPROVAL
1950-06-02
LATEST ACTION
2009-03-13
ROUTE
ORAL, INJECTION
DOSAGE FORM
CAPSULE, INJECTABLE
MARKETING STATUS
Discontinued
Products
PRONESTYL · ReferenceDiscontinued
PROCAINAMIDE HYDROCHLORIDE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
PRONESTYL · ReferenceDiscontinued
PROCAINAMIDE HYDROCHLORIDE 375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
PRONESTYL · ReferenceDiscontinued
PROCAINAMIDE HYDROCHLORIDE 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
PRONESTYL · ReferenceDiscontinued
PROCAINAMIDE HYDROCHLORIDE 500MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
PRONESTYL · ReferenceDiscontinued
PROCAINAMIDE HYDROCHLORIDE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
Approval history
2009-03-13Efficacy · Supplement 31AP
1997-05-06Labeling · Supplement 61 · standardAP
1995-09-12Manufacturing (CMC) · Supplement 60 · priorityAP
1992-06-08Manufacturing (CMC) · Supplement 59 · priorityAP
1991-10-03Efficacy · Supplement 58AP
1989-12-22Manufacturing (CMC) · Supplement 57 · priorityAP
1989-03-30Labeling · Supplement 56AP
1989-03-30Labeling · Supplement 53AP
1987-10-09Manufacturing (CMC) · Supplement 55 · priorityAP
1987-06-12Labeling · Supplement 54AP
1986-05-20Manufacturing (CMC) · Supplement 52 · priorityAP
1985-05-29Manufacturing (CMC) · Supplement 49 · priorityAP
1985-05-09Labeling · Supplement 45AP
1985-05-09Labeling · Supplement 43AP
1984-05-07Manufacturing (CMC) · Supplement 51 · priorityAP
1983-10-12Manufacturing (CMC) · Supplement 50 · priorityAP
1983-05-04Manufacturing (CMC) · Supplement 48 · priorityAP
1982-12-15Manufacturing (CMC) · Supplement 47 · priorityAP
1982-09-22Manufacturing (CMC) · Supplement 46 · priorityAP
1981-01-27Manufacturing (CMC) · Supplement 44 · priorityAP
1980-04-28Manufacturing (CMC) · Supplement 42 · priorityAP
1979-04-05Labeling · Supplement 40AP
1979-03-06Manufacturing (CMC) · Supplement 41 · priorityAP
1978-08-10Labeling · Supplement 30AP
1978-06-30Manufacturing (CMC) · Supplement 39 · priorityAP
1978-06-07Manufacturing (CMC) · Supplement 38 · priorityAP
1978-06-07Manufacturing (CMC) · Supplement 37 · priorityAP
1978-02-15Labeling · Supplement 33AP
1977-10-21Manufacturing (CMC) · Supplement 36 · priorityAP
1977-10-21Manufacturing (CMC) · Supplement 35 · priorityAP
1977-09-14Manufacturing (CMC) · Supplement 34 · priorityAP
1977-09-14Manufacturing (CMC) · Supplement 32 · priorityAP
1976-09-08Manufacturing (CMC) · Supplement 29 · priorityAP
1976-09-08REMS · Supplement 23 · priorityAP
1950-06-02Type 1 - New Molecular Entity · Original · priorityAP
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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