Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065046
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CEFUROXIME SODIUM | CEFUROXIME SODIUM | EQ 7.5GM BASE/VIAL | 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 |
---|---|---|---|---|---|---|---|
01/09/2004 | 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 |
---|---|---|---|---|---|
07/07/2021 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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07/07/2021 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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11/16/2019 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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05/06/2016 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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08/25/2008 | SUPPL-3 | Labeling |
Label is not available on this site. |