Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050821
Company: B BRAUN
Company: B BRAUN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | CEFEPIME HYDROCHLORIDE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | CEFEPIME HYDROCHLORIDE | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/06/2010 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050821s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050821s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/050821_cefepime_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/050821s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/18/2022 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050821s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050821Orig1s006ltr.pdf | |
11/09/2015 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (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/2015/050821s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050821Orig1s004ltr.pdf |
06/06/2014 | SUPPL-2 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050821s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050821Orig1s002ltr.pdf | |
09/06/2012 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050821s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050821Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/18/2022 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050821s006lbl.pdf | |
11/09/2015 | SUPPL-4 | 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/2015/050821s004lbl.pdf |
06/06/2014 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050821s002lbl.pdf | |
06/06/2014 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050821s002lbl.pdf | |
09/06/2012 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050821s001lbl.pdf | |
05/06/2010 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050821s000lbl.pdf |