NDA 17020, held by Abbott. Warfarin Sodium.
As of Nov 13, 2026, NDA 17020 (Panwarfin), held by Abbott, was first approved by FDA on Aug 11, 1972, with 10 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 11, 1972 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Panwarfin2MG · tablet;oral | Warfarin Sodium | Discontinued |
| Panwarfin2.5MG · tablet;oral | Warfarin Sodium | Discontinued |
| Panwarfin5MG · tablet;oral | Warfarin Sodium | Discontinued |
| Panwarfin7.5MG · tablet;oral | Warfarin Sodium | Discontinued |
| Panwarfin10MG · tablet;oral | Warfarin Sodium | Discontinued |
| Feb 25, 1987 | Supplement 12Labeling · Standard review | Approved | None posted |
| Sep 25, 1984 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Jun 29, 1982 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Sep 26, 1980 | Supplement 8Labeling · Standard review | Approved | None posted |
| Mar 30, 1979 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Jan 11, 1979 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Apr 28, 1976 | Supplement 4Labeling · Standard review | Approved | None posted |
| Dec 12, 1975 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jun 23, 1975 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Mar 3, 1975 | Supplement 1REMS · Standard review | Approved | None posted |
| Aug 11, 1972 | Original applicationNew formulation or manufacturer · Standard 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
