Application Sponsors
ANDA 210226 | LUPIN ATLANTIS | |
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
Application Products
001 | CAPSULE, DELAYED RELEASE;ORAL | 120MG | 0 | DIMETHYL FUMARATE | DIMETHYL FUMARATE |
002 | CAPSULE, DELAYED RELEASE;ORAL | 240MG | 0 | DIMETHYL FUMARATE | DIMETHYL FUMARATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2018-12-11 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
LUPIN ATLANTIS
cder:Array
(
[0] => Array
(
[ApplNo] => 210226
[companyName] => LUPIN ATLANTIS
[docInserts] => ["",""]
[products] => [{"drugName":"DIMETHYL FUMARATE","activeIngredients":"DIMETHYL FUMARATE","strength":"120MG","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DIMETHYL FUMARATE","activeIngredients":"DIMETHYL FUMARATE","strength":"240MG","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/06\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-10-06
)
)