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. |
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06/28/2023 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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04/28/2021 | SUPPL-13 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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05/09/2016 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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10/20/2004 | SUPPL-5 | Labeling |
Label is not available on this site. |
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11/20/2002 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |