APPLICATION
NDA017447
TYPE
NDA
ORIGINAL APPROVAL
1977-09-01
LATEST ACTION
2000-05-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
NORPACE · ReferencePrescription
DISOPYRAMIDE PHOSPHATE EQ 100MG BASE · CAPSULE · ORAL
NORPACE · ReferencePrescription
DISOPYRAMIDE PHOSPHATE EQ 150MG BASE · CAPSULE · ORAL
Approval history
2000-05-17Labeling · Supplement 55 · standardAP
1998-11-10Labeling · Supplement 54 · standardAP
1998-07-17Manufacturing (CMC) · Supplement 53 · priorityAP
1998-02-03Labeling · Supplement 52 · standardAP
1997-01-13Manufacturing (CMC) · Supplement 51 · priorityAP
1996-06-28Labeling · Supplement 50 · standardAP
1996-02-09Manufacturing (CMC) · Supplement 49 · priorityAP
1992-01-16Labeling · Supplement 47AP
1991-07-03Efficacy · Supplement 48AP
1989-11-16Labeling · Supplement 46AP
1989-10-20Labeling · Supplement 45AP
1988-02-04Manufacturing (CMC) · Supplement 44 · priorityAP
1987-08-28Labeling · Supplement 43AP
1987-08-28Labeling · Supplement 42AP
1987-02-12Labeling · Supplement 41AP
1986-06-04Manufacturing (CMC) · Supplement 38 · priorityAP
1986-05-30Labeling · Supplement 39AP
1985-06-19Labeling · Supplement 25AP
1985-06-19Labeling · Supplement 21AP
1985-06-19Labeling · Supplement 34AP
1985-06-18Labeling · Supplement 37AP
1985-01-25Manufacturing (CMC) · Supplement 35 · priorityAP
1984-02-29Labeling · Supplement 33AP
1983-10-03Labeling · Supplement 31AP
1983-09-14Manufacturing (CMC) · Supplement 32 · priorityAP
1983-09-06Manufacturing (CMC) · Supplement 30 · priorityAP
1983-06-10Manufacturing (CMC) · Supplement 28 · priorityAP
1982-09-21Labeling · Supplement 26AP
1982-06-17Labeling · Supplement 24AP
1981-11-30Labeling · Supplement 20AP
1981-11-30Labeling · Supplement 23AP
1981-02-20Labeling · Supplement 22AP
1981-01-30Labeling · Supplement 19AP
1980-10-17Manufacturing (CMC) · Supplement 18 · priorityAP
1980-10-15Manufacturing (CMC) · Supplement 16 · priorityAP
1980-02-05Manufacturing (CMC) · Supplement 15 · priorityAP
1980-01-30Labeling · Supplement 12AP
1980-01-30Labeling · Supplement 10AP
1980-01-30Labeling · Supplement 9AP
1980-01-30Labeling · Supplement 13AP
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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