Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078062
Company: BAXTER HLTHCARE CORP
Company: BAXTER HLTHCARE CORP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CIPROFLOXACIN | CIPROFLOXACIN | 200MG/20ML (10MG/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| CIPROFLOXACIN | CIPROFLOXACIN | 400MG/40ML (10MG/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 |
|---|---|---|---|---|---|---|---|
| 04/29/2008 | 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 |
|---|---|---|---|---|---|
| 05/06/2019 | SUPPL-18 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/06/2019 | SUPPL-17 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 10/18/2018 | SUPPL-16 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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| 10/15/2018 | SUPPL-15 | Labeling-Package Insert, Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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| 01/27/2017 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/27/2017 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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| 06/07/2016 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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| 06/07/2016 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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| 06/07/2016 | SUPPL-9 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 09/26/2012 | SUPPL-8 | REMS-Modified, Labeling-Medication Guide |
Label is not available on this site. |
||
| 05/24/2012 | SUPPL-7 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 05/16/2011 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 01/29/2010 | SUPPL-3 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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| 05/26/2009 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 01/29/2009 | SUPPL-1 | Labeling |
Label is not available on this site. |