Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050674
Company: PHARMACIA AND UPJOHN
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VANTIN | CEFPODOXIME PROXETIL | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
VANTIN | CEFPODOXIME PROXETIL | EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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. |
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09/28/1995 | SUPPL-9 | Labeling |
Label is not available on this site. |
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03/14/1996 | SUPPL-8 | Labeling |
Label is not available on this site. |
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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. |
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04/08/1993 | SUPPL-2 | Labeling |
Label is not available on this site. |
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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 |