Application Sponsors
| ANDA 084442 | WATSON LABS TEVA | |
Marketing Status
Application Products
| 004 | TABLET;ORAL | 500MG | 0 | PROBENECID | PROBENECID |
FDA Submissions
| ORIG | 1 | AP | 1977-03-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1983-03-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1983-03-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1984-02-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1985-01-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 1985-06-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1985-06-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 1988-11-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 1988-11-15 | |
| LABELING; Labeling | SUPPL | 41 | AP | 1989-04-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 1990-06-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 1991-08-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 45 | AP | 1991-01-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 46 | AP | 1993-11-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 49 | AP | 2000-10-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 50 | AP | 2001-04-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 51 | AP | 2002-04-29 | |
Submissions Property Types
| SUPPL | 29 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 40 | Null | 0 |
| SUPPL | 43 | Null | 0 |
| SUPPL | 44 | Null | 0 |
| SUPPL | 45 | Null | 0 |
| SUPPL | 46 | Null | 0 |
| SUPPL | 49 | Null | 0 |
| SUPPL | 50 | Null | 0 |
| SUPPL | 51 | Null | 0 |
TE Codes
CDER Filings
WATSON LABS TEVA
cder:Array
(
[0] => Array
(
[ApplNo] => 84442
[companyName] => WATSON LABS TEVA
[docInserts] => ["",""]
[products] => [{"drugName":"PROBENECID","activeIngredients":"PROBENECID","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
[labels] =>
[originalApprovals] => [{"actionDate":"PROBENECID","submission":"PROBENECID","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)