Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050551
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/18/1982 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/28/2017 SUPPL-45 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/2017/050551s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050551Orig1s045ltr.pdf
06/18/2018 SUPPL-44 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050551s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050551Orig1s044ltr.pdf
03/18/2015 SUPPL-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050551s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050551Orig1s043ltr.pdf
12/18/2002 SUPPL-42 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50551slr042_Cefobid_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50551slr042ltr.pdf
12/07/2001 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

10/28/1994 SUPPL-40 Labeling

Label is not available on this site.

09/29/1988 SUPPL-38 Labeling

Label is not available on this site.

03/05/1990 SUPPL-19 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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