Application Sponsors
ANDA 203899 | LANNETT CO INC | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET, EXTENDED RELEASE;ORAL | 500MG | 0 | NIACIN | NIACIN |
002 | TABLET, EXTENDED RELEASE;ORAL | 1GM | 0 | NIACIN | NIACIN |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2017-06-16 | |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
LANNETT CO INC
cder:Array
(
[0] => Array
(
[ApplNo] => 203899
[companyName] => LANNETT CO INC
[docInserts] => ["",""]
[products] => [{"drugName":"NIACIN","activeIngredients":"NIACIN","strength":"500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NIACIN","activeIngredients":"NIACIN","strength":"1GM","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/16\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2017-06-16
)
)