Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 050674
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VANTIN CEFPODOXIME PROXETIL EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
VANTIN CEFPODOXIME PROXETIL EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
08/07/1992 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
06/21/2013 SUPPL-15 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-14 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-13 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-12 Efficacy-New Indication Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/50674s12ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050674s012.cfm
02/07/1996 SUPPL-10 Labeling

Label is not available on this site.

09/28/1995 SUPPL-9 Labeling

Label is not available on this site.

03/14/1996 SUPPL-8 Labeling

Label is not available on this site.

03/14/1996 SUPPL-7 Efficacy-New Indication

Label is not available on this site.

05/07/1996 SUPPL-5 Efficacy-New Dosing Regimen

Label is not available on this site.

07/06/1994 SUPPL-4 Labeling

Label is not available on this site.

11/02/1993 SUPPL-3 Labeling

Label is not available on this site.

04/08/1993 SUPPL-2 Labeling

Label is not available on this site.

05/28/1993 SUPPL-1 Efficacy-New Indication

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/21/2013 SUPPL-15 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-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050674s014,050675s017lbl.pdf
06/02/2004 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50675slr013,016_vantin_lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English