Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090367
Company: CELLTRION
Company: CELLTRION
| 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 |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| 02/11/2021 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/03/2019 | SUPPL-4 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/19/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/24/2012 | SUPPL-2 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 01/12/2012 | SUPPL-1 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |