Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075228
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|---|---|
| 04/26/1999 | 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 |
|---|---|---|---|---|---|
| 11/09/2022 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/28/2021 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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| 03/08/2011 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 08/05/2008 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 07/21/2007 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 02/07/2007 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 04/03/2001 | SUPPL-1 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |