Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050817
Company: BAXTER HLTHCARE
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFEPIME IN PLASTIC CONTAINER | CEFEPIME HYDROCHLORIDE | EQ 1GM BASE/50ML (EQ 20MG BASE/ML) | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| CEFEPIME IN PLASTIC CONTAINER | CEFEPIME HYDROCHLORIDE | EQ 2GM BASE/100ML (EQ 20MG BASE/ML) | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/25/2026 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050817s015lbl.pdf | |
| 07/29/2025 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/050817s012lbl.pdf | |
| 05/01/2020 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050817s008lbl.pdf | |
| 05/09/2016 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050817s007lbl.pdf |
| 06/04/2014 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050817s003lbl.pdf | |
| 09/06/2012 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050817s004lbl.pdf | |
| 06/30/2010 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050817s001lbl.pdf |