Application Sponsors
ANDA 088337 | WATSON LABS INC | |
Marketing Status
Application Products
001 | TABLET;SUBLINGUAL | 2MG | 0 | ERGOSTAT | ERGOTAMINE TARTRATE |
FDA Submissions
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1987-07-09 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1987-07-09 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1989-01-19 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1989-01-19 | |
LABELING; Labeling | SUPPL | 10 | AP | 1988-09-26 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1991-06-14 | |
Submissions Property Types
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 12 | Null | 0 |
CDER Filings
WATSON LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 88337
[companyName] => WATSON LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"ERGOSTAT","activeIngredients":"ERGOTAMINE TARTRATE","strength":"2MG","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ERGOSTAT","submission":"ERGOTAMINE TARTRATE","actionType":"2MG","submissionClassification":"TABLET;SUBLINGUAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)