Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019698
Company: ROCHE PALO
Company: ROCHE PALO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TORADOL | KETOROLAC TROMETHAMINE | 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| TORADOL | KETOROLAC TROMETHAMINE | 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/30/1989 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/17/1999 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/09/1998 | SUPPL-15 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 10/25/1995 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/04/1995 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/07/1994 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 04/24/1992 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 04/24/1992 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 12/17/1991 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/07/1994 | SUPPL-4 | Efficacy-New Route Of Administration |
Label is not available on this site. |
||
| 11/18/1991 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 04/15/1991 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/01/1990 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |