Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021222
Company: VANSEN PHARMA
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 |