Application Sponsors
| ANDA 204841 | LANNETT CO INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | SPRAY;NASAL | 5MG/SPRAY | 0 | SUMATRIPTAN | SUMATRIPTAN |
| 002 | SPRAY;NASAL | 20MG/SPRAY | 0 | SUMATRIPTAN | SUMATRIPTAN |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2016-02-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2018-06-26 | UNKNOWN |
| LABELING; Labeling | SUPPL | 11 | AP | 2018-06-26 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 11 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
LANNETT CO INC
cder:Array
(
[0] => Array
(
[ApplNo] => 204841
[companyName] => LANNETT CO INC
[docInserts] => ["",""]
[products] => [{"drugName":"SUMATRIPTAN","activeIngredients":"SUMATRIPTAN","strength":"5MG\/SPRAY","dosageForm":"SPRAY;NASAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SUMATRIPTAN","activeIngredients":"SUMATRIPTAN","strength":"20MG\/SPRAY","dosageForm":"SPRAY;NASAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"02\/19\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"06\/26\/2018","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/26\/2018","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2018-06-26
)
)