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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050675
Company: PHARMACIA AND UPJOHN

Products on NDA 050675

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VANTIN	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION;ORAL	Discontinued	None	Yes	No
VANTIN	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050675

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/07/1992	ORIG-1	Approval	Type 3 - New Dosage Form	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
06/21/2013	SUPPL-18	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/2013/050674s015,050675s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050674Orig1s015,050675Orig1s018ltr.pdf
06/05/2007	SUPPL-17	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050674s014,050675s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050674s014, 050675s017ltr.pdf
06/02/2004	SUPPL-16	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50675slr013,016_vantin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50675slr013,016ltr.pdf
11/20/1998	SUPPL-15	Efficacy-New Indication	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/50675s14ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050674s012.cfm
11/20/1998	SUPPL-14	Efficacy-New Dosing Regimen	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/50675s14ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/50675S14_Vantin.cfm
03/19/1997	SUPPL-13	Labeling		Label is not available on this site.
12/09/1996	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
09/28/1995	SUPPL-11	Labeling		Label is not available on this site.
03/14/1996	SUPPL-10	Labeling		Label is not available on this site.
03/14/1996	SUPPL-9	Efficacy-New Indication		Label is not available on this site.
05/07/1996	SUPPL-8	Efficacy-New Dosing Regimen		Label is not available on this site.
07/06/1994	SUPPL-7	Labeling		Label is not available on this site.
11/02/1993	SUPPL-6	Labeling		Label is not available on this site.
10/20/1993	SUPPL-5	Labeling		Label is not available on this site.
04/22/1993	SUPPL-4	Labeling		Label is not available on this site.
06/16/1995	SUPPL-3	Efficacy-Accelerated Approval Confirmatory Study		Label is not available on this site.
04/08/1993	SUPPL-2	Labeling		Label is not available on this site.
10/12/1993	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 050675

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/21/2013	SUPPL-18	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/2013/050674s015,050675s018lbl.pdf
06/05/2007	SUPPL-17	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050674s014,050675s017lbl.pdf
06/02/2004	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50675slr013,016_vantin_lbl.pdf

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