NDA 20720, held by Pfizer Pharms. Troglitazone.
As of Nov 13, 2026, NDA 20720 (Rezulin), held by Pfizer Pharms, was first approved by FDA on Jan 29, 1997, with 11 approved supplements and 0 published complete response letters.
| Jun 16, 1999 | Supplement 12Efficacy (new indication or use) · Priority review | Approved | |
| Aug 4, 1997 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | |
| Aug 4, 1997 | Supplement 3Efficacy (new indication or use) · Priority review | Approved | |
| Jan 29, 1997 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Rezulin200MG · tablet;oral | Troglitazone | Discontinued |
| Rezulin400MG · tablet;oral | Troglitazone | Discontinued |
| Rezulin300MG · tablet;oral | Troglitazone | Discontinued |
| Jun 16, 1999 | Supplement 12Efficacy (new indication or use) · Priority review | Approved | |
| Jun 16, 1999 | Supplement 14Labeling · Priority review | Approved | |
| Nov 2, 1998 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Jul 22, 1998 | Supplement 10Labeling · Priority review | Approved | None posted |
| Dec 15, 1997 | Supplement 7Labeling · Priority review | Approved | |
| Nov 19, 1997 | Supplement 6Labeling · Priority review | Approved | |
| Aug 4, 1997 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | |
| Aug 4, 1997 | Supplement 3Efficacy (new indication or use) · Priority review | Approved | |
| Aug 4, 1997 | Supplement 5Manufacturing · Priority review | Approved | |
| Apr 4, 1997 | Supplement 1Labeling · Priority review | Approved | |
| Apr 4, 1997 | Supplement 4Labeling · Priority review | Approved | |
| Jan 29, 1997 | 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
