Application Sponsors
| ANDA 063008 | WATSON LABS INC | |
Marketing Status
Application Products
| 001 | INJECTABLE;INJECTION | EQ 10GM BASE/VIAL | 0 | NAFCILLIN SODIUM | NAFCILLIN SODIUM |
FDA Submissions
| ORIG | 1 | AP | 1988-09-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1988-12-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1990-11-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1993-02-16 | |
| LABELING; Labeling | SUPPL | 6 | AP | 1994-03-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1993-11-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1994-01-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1995-01-27 | |
| LABELING; Labeling | SUPPL | 11 | AP | 1996-03-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1995-12-15 | |
| LABELING; Labeling | SUPPL | 13 | AP | 1997-07-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1997-12-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2000-12-08 | |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 18 | Null | 0 |
CDER Filings
WATSON LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 63008
[companyName] => WATSON LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"NAFCILLIN SODIUM","activeIngredients":"NAFCILLIN SODIUM","strength":"EQ 10GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"NAFCILLIN SODIUM","submission":"NAFCILLIN SODIUM","actionType":"EQ 10GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)