Documents
Application Sponsors
| NDA 050675 | PHARMACIA AND UPJOHN | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | FOR SUSPENSION;ORAL | EQ 50MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | VANTIN | CEFPODOXIME PROXETIL |
| 002 | FOR SUSPENSION;ORAL | EQ 100MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | VANTIN | CEFPODOXIME PROXETIL |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1992-08-07 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 1993-04-08 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 1995-06-16 | UNKNOWN |
| LABELING; Labeling | SUPPL | 4 | AP | 1993-04-22 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 1993-10-20 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 1993-11-02 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 1994-07-06 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 1996-05-07 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 9 | AP | 1996-03-14 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 1996-03-14 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 1995-09-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1996-12-09 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 1997-03-19 | |
| EFFICACY; Efficacy | SUPPL | 14 | AP | 1998-11-20 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 15 | AP | 1998-11-20 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2004-06-02 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2007-06-05 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2013-06-21 | STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
Submissions Property Types
CDER Filings
PHARMACIA AND UPJOHN
cder:Array
(
[0] => Array
(
[ApplNo] => 50675
[companyName] => PHARMACIA AND UPJOHN
[docInserts] => ["",""]
[products] => [{"drugName":"VANTIN","activeIngredients":"CEFPODOXIME PROXETIL","strength":"EQ 50MG BASE\/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"VANTIN","activeIngredients":"CEFPODOXIME PROXETIL","strength":"EQ 100MG BASE\/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"06\/21\/2013","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/050674s015,050675s018lbl.pdf\"}]","notes":"Please see"},{"actionDate":"06\/05\/2007","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050674s014,050675s017lbl.pdf\"}]","notes":""},{"actionDate":"06\/02\/2004","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/50675slr013,016_vantin_lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"VANTIN","submission":"CEFPODOXIME PROXETIL","actionType":"EQ 50MG BASE\/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"VANTIN","submission":"CEFPODOXIME PROXETIL","actionType":"EQ 100MG BASE\/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2013-06-21
)
)