Documents
Application Sponsors
| NDA 050517 | MYLAN INSTITUTIONAL | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
Application Products
| 001 | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | MEFOXIN | CEFOXITIN SODIUM |
| 002 | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | MEFOXIN | CEFOXITIN SODIUM |
| 003 | INJECTABLE;INJECTION | EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | MEFOXIN | CEFOXITIN SODIUM |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1978-10-18 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 28 | AP | 1996-07-30 | |
| EFFICACY; Efficacy | SUPPL | 29 | AP | 1995-02-28 | |
| LABELING; Labeling | SUPPL | 31 | AP | 1997-02-27 | |
| LABELING; Labeling | SUPPL | 32 | AP | 1996-05-20 | |
| LABELING; Labeling | SUPPL | 33 | AP | 1994-10-27 | STANDARD |
| LABELING; Labeling | SUPPL | 35 | AP | 1996-05-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1994-11-30 | PRIORITY |
| LABELING; Labeling | SUPPL | 37 | AP | 1996-10-11 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 2000-02-14 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 1997-04-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 1999-10-12 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 2001-10-19 | PRIORITY |
| LABELING; Labeling | SUPPL | 42 | AP | 2004-06-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 2002-05-07 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 2002-06-06 | PRIORITY |
| LABELING; Labeling | SUPPL | 45 | AP | 2004-06-28 | STANDARD |
| LABELING; Labeling | SUPPL | 46 | AP | 2004-06-02 | STANDARD |
| LABELING; Labeling | SUPPL | 47 | AP | 2007-09-17 | STANDARD |
| LABELING; Labeling | SUPPL | 50 | AP | 2011-02-04 | UNKNOWN |
| LABELING; Labeling | SUPPL | 51 | AP | 2013-05-10 | STANDARD |
| LABELING; Labeling | SUPPL | 53 | AP | 2017-03-09 | STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
Submissions Property Types
| SUPPL | 36 | Null | 0 |
| SUPPL | 40 | Null | 0 |
| SUPPL | 41 | Null | 0 |
| SUPPL | 43 | Null | 0 |
| SUPPL | 44 | Null | 0 |
| SUPPL | 46 | Null | 9 |
| SUPPL | 50 | Null | 31 |
| SUPPL | 51 | Null | 15 |
| SUPPL | 53 | Null | 15 |
CDER Filings
MYLAN INSTITUTIONAL
cder:Array
(
[0] => Array
(
[ApplNo] => 50517
[companyName] => MYLAN INSTITUTIONAL
[docInserts] => ["",""]
[products] => [{"drugName":"MEFOXIN","activeIngredients":"CEFOXITIN SODIUM","strength":"EQ 1GM BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"MEFOXIN","activeIngredients":"CEFOXITIN SODIUM","strength":"EQ 2GM BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"MEFOXIN","activeIngredients":"CEFOXITIN SODIUM","strength":"EQ 10GM BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"03\/09\/2017","submission":"SUPPL-53","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/050517s053lbl.pdf\"}]","notes":"Please see"},{"actionDate":"05\/10\/2013","submission":"SUPPL-51","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/050517s051lbl.pdf\"}]","notes":""},{"actionDate":"09\/17\/2007","submission":"SUPPL-47","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050517s047lbl.pdf\"}]","notes":""},{"actionDate":"06\/02\/2004","submission":"SUPPL-46","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/50517slr046_mefoxin_lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"MEFOXIN","submission":"CEFOXITIN SODIUM","actionType":"EQ 1GM BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"MEFOXIN","submission":"CEFOXITIN SODIUM","actionType":"EQ 2GM BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"MEFOXIN","submission":"CEFOXITIN SODIUM","actionType":"EQ 10GM BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2017-03-09
)
)