Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090787
Company: APOTEX INC
Company: APOTEX INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LEVOFLOXACIN | LEVOFLOXACIN | 250MG | TABLET;ORAL | Discontinued | None | No | No |
| LEVOFLOXACIN | LEVOFLOXACIN | 500MG | TABLET;ORAL | Discontinued | None | No | No |
| LEVOFLOXACIN | LEVOFLOXACIN | 750MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/29/2011 | 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 |
|---|---|---|---|---|---|
| 09/20/2024 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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| 02/11/2021 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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| 06/02/2020 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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| 06/02/2020 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/06/2019 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 04/24/2019 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 04/24/2019 | SUPPL-8 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 04/24/2019 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 04/24/2019 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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| 09/24/2014 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/24/2014 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/31/2013 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/22/2013 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |