Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050792
Company: B BRAUN
Company: B BRAUN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER | CEFOTAXIME SODIUM | EQ 2GM BASE | INJECTABLE;INJECTION | Discontinued | None | No | No |
CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER | CEFOTAXIME SODIUM | EQ 1GM BASE | 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 |
---|---|---|---|---|---|---|---|
07/29/2004 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50792lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50792ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/050792s000_Duplex_ContainerTOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/10/2007 | SUPPL-2 | Labeling |
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/2007/050792s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050792s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/10/2007 | SUPPL-2 | Labeling | 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/2007/050792s002lbl.pdf |
07/29/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50792lbl.pdf |