Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075626
Company: APOTEX INC
Company: APOTEX INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 07/24/2001 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/28/2023 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/28/2023 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/28/2021 | SUPPL-13 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/20/2004 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 11/20/2002 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |