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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050551
Company: PFIZER

Products on NDA 050551

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050551

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
09/18/2020	SUPPL-46	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050551s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050551Orig1s046ltr.pdf
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.

Labels for NDA 050551

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

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