Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021222
Company: VANSEN PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SPECTRACEF CEFDITOREN PIVOXIL 200MG TABLET;ORAL Discontinued None No No
SPECTRACEF CEFDITOREN PIVOXIL 400MG TABLET;ORAL 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
08/29/2001 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21222lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21222ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-222_Spectracef.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/06/2012 SUPPL-16 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/2012/021222s013s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021222Orig1s013,s016ltr.pdf
08/06/2012 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021222s013s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021222Orig1s013,s016ltr.pdf
07/21/2008 SUPPL-12 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021222s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021222s012ltr.pdf
12/20/2005 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021222s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021222s009ltr.pdf
09/23/2009 SUPPL-6 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021222s006ltr.pdf
03/23/2004 SUPPL-3 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21222s003ltr.pdf
06/11/2002 SUPPL-2 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/21/2002 SUPPL-1 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21222s1lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21222se1-001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/06/2012 SUPPL-16 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/2012/021222s013s016lbl.pdf
08/06/2012 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021222s013s016lbl.pdf
07/21/2008 SUPPL-12 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021222s012lbl.pdf
12/20/2005 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021222s009lbl.pdf
08/21/2002 SUPPL-1 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21222s1lbl.pdf
08/29/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21222lbl.pdf

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