Application Sponsors
| ANDA 070528 | WATSON LABS TEVA | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 80MG | 0 | FUROSEMIDE | FUROSEMIDE |
FDA Submissions
| ORIG | 1 | AP | 1986-01-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1986-10-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1987-06-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1988-06-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1988-06-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1988-06-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1988-11-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1990-05-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1990-07-18 | |
| LABELING; Labeling | SUPPL | 13 | AP | 1990-04-12 | |
| LABELING; Labeling | SUPPL | 14 | AP | 1990-12-04 | |
| LABELING; Labeling | SUPPL | 15 | AP | 1990-12-04 | |
| LABELING; Labeling | SUPPL | 16 | AP | 1992-06-02 | |
| LABELING; Labeling | SUPPL | 17 | AP | 1992-08-24 | |
| LABELING; Labeling | SUPPL | 18 | AP | 1993-04-08 | |
| LABELING; Labeling | SUPPL | 19 | AP | 1993-06-11 | |
| LABELING; Labeling | SUPPL | 20 | AP | 1996-04-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1999-06-23 | |
| LABELING; Labeling | SUPPL | 22 | AP | 1998-12-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1999-11-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 2001-08-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 2002-11-07 | |
| LABELING; Labeling | SUPPL | 26 | AP | 2005-08-04 | |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
CDER Filings
WATSON LABS TEVA
cder:Array
(
[0] => Array
(
[ApplNo] => 70528
[companyName] => WATSON LABS TEVA
[docInserts] => ["",""]
[products] => [{"drugName":"FUROSEMIDE","activeIngredients":"FUROSEMIDE","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"FUROSEMIDE","submission":"FUROSEMIDE","actionType":"80MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)