Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075222
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |
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TROMETHAMINE | KETOROLAC TROMETHAMINE | 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |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 |
---|---|---|---|---|---|
07/11/2024 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
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11/09/2022 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
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04/28/2021 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
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03/08/2011 | SUPPL-14 | Labeling |
Label is not available on this site. |
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08/05/2008 | SUPPL-13 | Labeling |
Label is not available on this site. |
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07/21/2007 | SUPPL-12 | Labeling |
Label is not available on this site. |
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02/07/2007 | SUPPL-11 | Labeling |
Label is not available on this site. |
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12/20/2002 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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09/17/2002 | SUPPL-2 | Manufacturing (CMC)-Packaging |
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. |