Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050551
Company: PFIZER
Company: PFIZER
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CEFOBID | CEFOPERAZONE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
CEFOBID | CEFOPERAZONE SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
CEFOBID | CEFOPERAZONE SODIUM | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/18/2020 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050551s046lbl.pdf | |
06/18/2018 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050551s044lbl.pdf | |
09/28/2017 | SUPPL-45 | 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/2017/050551s045lbl.pdf |
03/18/2015 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050551s043lbl.pdf | |
12/18/2002 | SUPPL-42 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50551slr042_Cefobid_lbl.pdf |