Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065069
Company: APOTEX
Company: APOTEX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFUROXIME AXETIL | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| CEFUROXIME AXETIL | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 10/02/2002 | 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 |
|---|---|---|---|---|---|
| 06/09/2022 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/19/2019 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/19/2019 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/11/2017 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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| 03/24/2016 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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| 09/22/2015 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/06/2009 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 09/01/2005 | SUPPL-5 | Labeling |
Label is not available on this site. |