Application Sponsors
ANDA 072952 | WATSON LABS TEVA | |
Marketing Status
Application Products
001 | CAPSULE;ORAL | 10MG | 0 | OXAZEPAM | OXAZEPAM |
FDA Submissions
| ORIG | 1 | AP | 1990-09-28 | |
LABELING; Labeling | SUPPL | 2 | AP | 1993-10-19 | |
LABELING; Labeling | SUPPL | 3 | AP | 1998-04-21 | |
LABELING; Labeling | SUPPL | 5 | AP | 2016-12-16 | STANDARD |
LABELING; Labeling | SUPPL | 6 | AP | 2021-02-05 | STANDARD |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 5 | Null | 15 |
SUPPL | 6 | Null | 7 |
CDER Filings
WATSON LABS TEVA
cder:Array
(
[0] => Array
(
[ApplNo] => 72952
[companyName] => WATSON LABS TEVA
[docInserts] => ["",""]
[products] => [{"drugName":"OXAZEPAM","activeIngredients":"OXAZEPAM","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"OXAZEPAM","submission":"OXAZEPAM","actionType":"10MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)