NDA 17447, held by Pfizer. Disopyramide Phosphate.
As of Nov 13, 2026, NDA 17447 (Norpace), held by Pfizer, was first approved by FDA on Sep 1, 1977, with 47 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Disopyramide phosphate is indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of disopyramide phosphate, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of disopyramide phosphate treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 3, 1991 | Supplement 48Efficacy (new indication or use) | Approved | None posted |
| Jul 19, 1979 | Supplement 3Efficacy (new indication or use) | Approved | None posted |
| Sep 1, 1977 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| NorpaceEQ 100MG BASE · capsule;oral | Disopyramide Phosphate | RxReference drug |
| NorpaceEQ 150MG BASE · capsule;oral | Disopyramide Phosphate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 17, 2000 | Supplement 55Labeling · Standard review | Approved | None posted |
| Nov 10, 1998 | Supplement 54Labeling · Standard review | Approved | None posted |
| Jul 17, 1998 | Supplement 53Manufacturing · Priority review | Approved | None posted |
| Feb 3, 1998 | Supplement 52Labeling · Standard review | Approved | None posted |
| Jan 13, 1997 | Supplement 51Manufacturing · Priority review | Approved | None posted |
| Jun 28, 1996 | Supplement 50Labeling · Standard review | Approved | None posted |
| Feb 9, 1996 | Supplement 49Manufacturing · Priority review | Approved | None posted |
| Jan 16, 1992 | Supplement 47Labeling | Approved | None posted |
| Jul 3, 1991 | Supplement 48Efficacy (new indication or use) | Approved | None posted |
| Nov 16, 1989 | Supplement 46Labeling | Approved | None posted |
| Oct 20, 1989 | Supplement 45Labeling | Approved | None posted |
| Feb 4, 1988 | Supplement 44Manufacturing · Priority review | Approved | None posted |
| Aug 28, 1987 | Supplement 42Labeling | Approved | None posted |
| Aug 28, 1987 | Supplement 43Labeling | Approved | None posted |
| Feb 12, 1987 | Supplement 41Labeling | Approved | None posted |
| Jun 4, 1986 | Supplement 38Manufacturing · Priority review | Approved | None posted |
| May 30, 1986 | Supplement 39Labeling | Approved | None posted |
| Jun 19, 1985 | Supplement 34Labeling | Approved | None posted |
| Jun 19, 1985 | Supplement 25Labeling | Approved | None posted |
| Jun 19, 1985 | Supplement 21Labeling | Approved | None posted |
| Jun 18, 1985 | Supplement 37Labeling | Approved | None posted |
| Jan 25, 1985 | Supplement 35Manufacturing · Priority review | Approved | None posted |
| Feb 29, 1984 | Supplement 33Labeling | Approved | None posted |
| Oct 3, 1983 | Supplement 31Labeling | Approved | None posted |
| Sep 14, 1983 | Supplement 32Manufacturing · Priority review | Approved | None posted |
| Sep 6, 1983 | Supplement 30Manufacturing · Priority review | Approved | None posted |
| Jun 10, 1983 | Supplement 28Manufacturing · Priority review | Approved | None posted |
| Sep 21, 1982 | Supplement 26Labeling | Approved | None posted |
| Jun 17, 1982 | Supplement 24Labeling | Approved | None posted |
| Nov 30, 1981 | Supplement 23Labeling | Approved | None posted |
| Nov 30, 1981 | Supplement 20Labeling | Approved | None posted |
| Feb 20, 1981 | Supplement 22Labeling | Approved | None posted |
| Jan 30, 1981 | Supplement 19Labeling | Approved | None posted |
| Oct 17, 1980 | Supplement 18Manufacturing · Priority review | Approved | None posted |
| Oct 15, 1980 | Supplement 16Manufacturing · Priority review | Approved | None posted |
| Feb 5, 1980 | Supplement 15Manufacturing · Priority review | Approved | None posted |
| Jan 30, 1980 | Supplement 13Labeling | Approved | None posted |
| Jan 30, 1980 | Supplement 12Labeling | Approved | None posted |
| Jan 30, 1980 | Supplement 11Labeling | Approved | None posted |
| Jan 30, 1980 | Supplement 10Labeling | Approved | None posted |
| Jan 30, 1980 | Supplement 9Labeling | Approved | None posted |
| Nov 23, 1979 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Jul 19, 1979 | Supplement 3Efficacy (new indication or use) | Approved | None posted |
| Apr 26, 1979 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Sep 20, 1978 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Mar 2, 1978 | Supplement 2Labeling | Approved | None posted |
| Mar 2, 1978 | Supplement 1Labeling | Approved | None posted |
| Sep 1, 1977 | Original applicationNew molecular entity · Priority review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
