Application Sponsors
ANDA 072370 | WATSON LABS INC | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 5MG/ML | 0 | DIAZEPAM | DIAZEPAM |
FDA Submissions
| ORIG | 1 | AP | 1993-01-29 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1996-08-15 | |
LABELING; Labeling | SUPPL | 3 | AP | 1996-08-15 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1996-08-15 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1996-08-15 | |
LABELING; Labeling | SUPPL | 6 | AP | 2016-12-16 | STANDARD |
LABELING; Labeling | SUPPL | 7 | AP | 2021-02-08 | STANDARD |
LABELING; Labeling | SUPPL | 8 | AP | 2021-08-26 | STANDARD |
LABELING; Labeling | SUPPL | 9 | AP | 2021-08-26 | STANDARD |
LABELING; Labeling | SUPPL | 10 | AP | 2023-01-17 | STANDARD |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 6 | Null | 15 |
SUPPL | 7 | Null | 15 |
SUPPL | 8 | Null | 7 |
SUPPL | 9 | Null | 7 |
SUPPL | 10 | Null | 7 |
CDER Filings
WATSON LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 72370
[companyName] => WATSON LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"DIAZEPAM","activeIngredients":"DIAZEPAM","strength":"5MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"DIAZEPAM","submission":"DIAZEPAM","actionType":"5MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)