Application Sponsors
| ANDA 204433 | LANNETT CO INC | |
Marketing Status
Application Products
| 001 | CONCENTRATE;ORAL | 5MG/ML | 0 | DIAZEPAM | DIAZEPAM |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2014-04-14 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2016-03-24 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2021-02-04 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2021-02-05 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 6 | Null | 15 |
TE Codes
CDER Filings
LANNETT CO INC
cder:Array
(
[0] => Array
(
[ApplNo] => 204433
[companyName] => LANNETT CO INC
[docInserts] => ["",""]
[products] => [{"drugName":"DIAZEPAM","activeIngredients":"DIAZEPAM","strength":"5MG\/ML","dosageForm":"CONCENTRATE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"04\/14\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"03\/24\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2016-03-24
)
)