Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200560
Company: MYLAN ASI
Company: MYLAN ASI
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LEVOFLOXACIN | LEVOFLOXACIN | EQ 500MG/20ML (EQ 25MG/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| LEVOFLOXACIN | LEVOFLOXACIN | EQ 750MG/30ML (EQ 25MG/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 |
|---|---|---|---|---|---|---|---|
| 06/20/2011 | 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 |
|---|---|---|---|---|---|
| 05/03/2019 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/18/2018 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/17/2019 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/14/2016 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/14/2016 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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| 11/14/2012 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/28/2012 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/03/2012 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |