Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | INJECTABLE;INTRAVENOUS | EQ 750MG BASE/VIAL | 0 | KEFUROX | CEFUROXIME SODIUM |
| 002 | INJECTABLE;INJECTION | EQ 1.5GM BASE/VIAL | 0 | KEFUROX | CEFUROXIME SODIUM |
FDA Submissions
| ORIG | 1 | AP | 1986-01-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1992-06-12 | |
| LABELING; Labeling | SUPPL | 9 | AP | 1992-06-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1992-10-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1997-01-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1997-01-13 | |
| LABELING; Labeling | SUPPL | 14 | AP | 1997-01-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1996-08-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2001-01-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2001-01-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2001-01-22 | |
| LABELING; Labeling | SUPPL | 20 | AP | 2001-01-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2001-09-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2002-06-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 2002-09-04 | |
| LABELING; Labeling | SUPPL | 24 | AP | 2002-11-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 2002-09-30 | |
| LABELING; Labeling | SUPPL | 26 | AP | 2002-11-12 | |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 1 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 25 | Null | 0 |
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 62592
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)