Documents
Application Sponsors
ANDA 075152 | WATSON LABS TEVA | |
Marketing Status
Application Products
001 | TABLET;ORAL | 50MG | 0 | DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM |
FDA Submissions
| ORIG | 1 | AP | 1998-11-27 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2001-08-31 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2002-11-07 | |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
CDER Filings
WATSON LABS TEVA
cder:Array
(
[0] => Array
(
[ApplNo] => 75152
[companyName] => WATSON LABS TEVA
[docInserts] => ["",""]
[products] => [{"drugName":"DICLOFENAC POTASSIUM","activeIngredients":"DICLOFENAC POTASSIUM","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"DICLOFENAC POTASSIUM","submission":"DICLOFENAC POTASSIUM","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)