Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075299
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| 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 |
|---|---|---|---|---|---|---|---|
| 11/03/1999 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75229ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/21/2023 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/21/2023 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/28/2021 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/12/2000 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/12/2000 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |