NDA 19645, held by Roche Palo. Ketorolac Tromethamine.
As of Nov 13, 2026, NDA 19645 (Toradol), held by Roche Palo, was first approved by FDA on Dec 20, 1991, with 12 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 20, 1991 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Toradol10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Ketorolac Tromethamine | DiscontinuedReference drug |
| Mar 26, 2013 | Supplement 19Labeling · Standard review | Approved | |
| Dec 16, 2008 | Supplement 18Labeling · Standard review | Approved | |
| Nov 13, 2007 | Supplement 17Labeling · Standard review | Approved | |
| Jan 19, 2007 | Supplement 16Labeling · Standard review | Approved | |
| Oct 11, 2001 | Supplement 9Labeling · Standard review | Approved | None posted |
| Oct 11, 2001 | Supplement 8Labeling · Standard review | Approved | None posted |
| Oct 11, 2001 | Supplement 7Labeling · Standard review | Approved | None posted |
| Oct 11, 2001 | Supplement 6Labeling · Standard review | Approved | None posted |
| Oct 11, 2001 | Supplement 5Labeling · Standard review | Approved | None posted |
| Oct 11, 2001 | Supplement 3Labeling · Standard review | Approved | None posted |
| Dec 7, 1994 | Supplement 4Labeling · Standard review | Approved | None posted |
| Sep 18, 1992 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Dec 20, 1991 | Original applicationNew dosage form · 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
