Application Sponsors
ANDA 073353 | WATSON LABS TEVA | |
Marketing Status
Application Products
001 | TABLET;ORAL | 100MG | 0 | ATENOLOL | ATENOLOL |
FDA Submissions
| ORIG | 1 | AP | 1991-12-27 | |
LABELING; Labeling | SUPPL | 2 | AP | 1992-07-06 | |
LABELING; Labeling | SUPPL | 3 | AP | 1992-12-07 | |
LABELING; Labeling | SUPPL | 6 | AP | 1993-05-05 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1993-07-22 | |
LABELING; Labeling | SUPPL | 9 | AP | 1994-03-31 | |
LABELING; Labeling | SUPPL | 10 | AP | 1994-11-08 | |
LABELING; Labeling | SUPPL | 11 | AP | 1996-11-25 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1997-06-23 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1997-12-15 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1997-12-15 | |
LABELING; Labeling | SUPPL | 17 | AP | 2000-08-07 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2001-04-25 | |
LABELING; Labeling | SUPPL | 19 | AP | 2001-03-30 | |
LABELING; Labeling | SUPPL | 22 | AP | 2003-09-25 | |
LABELING; Labeling | SUPPL | 25 | AP | 2006-06-22 | |
LABELING; Labeling | SUPPL | 26 | AP | 2006-12-13 | |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 6 | Null | 1 |
SUPPL | 7 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 13 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 18 | Null | 0 |
CDER Filings
WATSON LABS TEVA
cder:Array
(
[0] => Array
(
[ApplNo] => 73353
[companyName] => WATSON LABS TEVA
[docInserts] => ["",""]
[products] => [{"drugName":"ATENOLOL","activeIngredients":"ATENOLOL","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ATENOLOL","submission":"ATENOLOL","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)