Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078084
Company: BAXTER HLTHCARE CORP
Company: BAXTER HLTHCARE CORP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METRONIDAZOLE IN PLASTIC CONTAINER | METRONIDAZOLE | 500MG/100ML | 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 |
|---|---|---|---|---|---|---|---|
| 03/31/2008 | 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 |
|---|---|---|---|---|---|
| 11/08/2019 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/08/2019 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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| 03/28/2012 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/08/2010 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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| 11/13/2009 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/15/2009 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 04/07/2011 | SUPPL-2 | Labeling |
Label is not available on this site. |