Application Sponsors
| ANDA 064035 | WATSON LABS INC | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | EQ 750MG BASE/VIAL | 0 | CEFUROXIME SODIUM | CEFUROXIME SODIUM |
| 002 | INJECTABLE;INJECTION | EQ 1.5GM BASE/VIAL | 0 | CEFUROXIME SODIUM | CEFUROXIME SODIUM |
FDA Submissions
| ORIG | 1 | AP | 1993-02-26 | |
| LABELING; Labeling | SUPPL | 2 | AP | 1993-05-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1993-08-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1994-03-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1994-03-15 | |
| LABELING; Labeling | SUPPL | 6 | AP | 1994-12-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1994-08-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1995-01-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1995-10-26 | |
| LABELING; Labeling | SUPPL | 10 | AP | 1996-03-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1996-07-02 | |
| LABELING; Labeling | SUPPL | 12 | AP | 1996-05-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1996-10-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1996-10-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1997-08-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1998-02-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1998-05-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2000-12-08 | |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
CDER Filings
WATSON LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 64035
[companyName] => WATSON LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"CEFUROXIME SODIUM","activeIngredients":"CEFUROXIME SODIUM","strength":"EQ 750MG BASE\/VIAL","dosageForm":"INJECTABLE;INTRAMUSCULAR, INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CEFUROXIME SODIUM","activeIngredients":"CEFUROXIME SODIUM","strength":"EQ 1.5GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CEFUROXIME SODIUM","submission":"CEFUROXIME SODIUM","actionType":"EQ 750MG BASE\/VIAL","submissionClassification":"INJECTABLE;INTRAMUSCULAR, INTRAVENOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CEFUROXIME SODIUM","submission":"CEFUROXIME SODIUM","actionType":"EQ 1.5GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)