Application Sponsors
| ANDA 209468 | LANNETT CO INC | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
Application Products
| 001 | TABLET;ORAL | 2.5MG | 0 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE |
| 002 | TABLET;ORAL | 5MG | 0 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE |
| 003 | TABLET;ORAL | 10MG | 0 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2017-09-25 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2019-11-29 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2021-06-25 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 3 | Null | 15 |
CDER Filings
LANNETT CO INC
cder:Array
(
[0] => Array
(
[ApplNo] => 209468
[companyName] => LANNETT CO INC
[docInserts] => ["",""]
[products] => [{"drugName":"DEXMETHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"DEXMETHYLPHENIDATE HYDROCHLORIDE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DEXMETHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"DEXMETHYLPHENIDATE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DEXMETHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"DEXMETHYLPHENIDATE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/25\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"11\/29\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-11-29
)
)