Application Sponsors
ANDA 064036 | WATSON LABS INC | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | EQ 7.5GM BASE/VIAL | 0 | CEFUROXIME SODIUM | CEFUROXIME SODIUM |
FDA Submissions
| ORIG | 1 | AP | 1993-02-26 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1993-08-26 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1994-03-15 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1994-03-15 | |
LABELING; Labeling | SUPPL | 5 | AP | 1994-12-13 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1994-08-18 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1995-03-17 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1995-10-27 | |
LABELING; Labeling | SUPPL | 9 | AP | 1996-03-06 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1996-07-03 | |
LABELING; Labeling | SUPPL | 11 | AP | 1996-05-06 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1996-10-04 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1996-10-04 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1997-08-20 | |
LABELING; Labeling | SUPPL | 15 | AP | 1997-07-15 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1998-02-23 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1998-08-26 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2000-12-08 | |
Submissions Property Types
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 10 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 13 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 17 | Null | 0 |
SUPPL | 18 | Null | 0 |
SUPPL | 19 | Null | 0 |
CDER Filings
WATSON LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 64036
[companyName] => WATSON LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"CEFUROXIME SODIUM","activeIngredients":"CEFUROXIME SODIUM","strength":"EQ 7.5GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CEFUROXIME SODIUM","submission":"CEFUROXIME SODIUM","actionType":"EQ 7.5GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)