Application Sponsors
| ANDA 062757 | MYLAN INSTITUTIONAL | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | 0 | MEFOXIN | CEFOXITIN SODIUM |
| 002 | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | 0 | MEFOXIN | CEFOXITIN SODIUM |
FDA Submissions
| ORIG | 1 | AP | 1987-01-08 | |
| LABELING; Labeling | SUPPL | 2 | AP | 1992-02-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1992-02-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1992-03-10 | |
| LABELING; Labeling | SUPPL | 8 | AP | 1997-07-11 | |
| LABELING; Labeling | SUPPL | 9 | AP | 1996-02-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1995-03-20 | |
| LABELING; Labeling | SUPPL | 11 | AP | 1996-07-16 | |
| LABELING; Labeling | SUPPL | 12 | AP | 1999-02-18 | |
| LABELING; Labeling | SUPPL | 13 | AP | 1996-02-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1996-05-08 | |
| LABELING; Labeling | SUPPL | 15 | AP | 2002-08-22 | |
| LABELING; Labeling | SUPPL | 16 | AP | 1997-07-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1999-12-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2001-12-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2002-06-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2002-06-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2002-09-30 | |
| LABELING; Labeling | SUPPL | 22 | AP | 2004-02-06 | |
| LABELING; Labeling | SUPPL | 23 | AP | 2004-02-06 | |
| LABELING; Labeling | SUPPL | 24 | AP | 2004-12-02 | |
| LABELING; Labeling | SUPPL | 25 | AP | 2008-01-31 | |
Submissions Property Types
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
CDER Filings
MYLAN INSTITUTIONAL
cder:Array
(
[0] => Array
(
[ApplNo] => 62757
[companyName] => MYLAN INSTITUTIONAL
[docInserts] => ["",""]
[products] => [{"drugName":"MEFOXIN","activeIngredients":"CEFOXITIN SODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MEFOXIN","activeIngredients":"CEFOXITIN SODIUM","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"MEFOXIN","submission":"CEFOXITIN SODIUM","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MEFOXIN","submission":"CEFOXITIN SODIUM","actionType":"EQ 2GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)