Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076209
Company: AMPHASTAR PHARM
Company: AMPHASTAR PHARM
| 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 |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 60MG/2ML | INJECTABLE; INJECTION | Prescription | 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 |
|---|---|---|---|---|---|---|---|
| 07/21/2004 | 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 |
|---|---|---|---|---|---|
| 09/22/2023 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/22/2023 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/29/2021 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/10/2016 | SUPPL-2 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-1 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |