Documents
Application Sponsors
NDA 213092 | SUN PHARM INDS INC | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | CAPSULE; ORAL | 4MG | 0 | LENVATINIB | LENVATINIB |
002 | CAPSULE; ORAL | 10MG | 0 | LENVATINIB | LENVATINIB |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2022-03-01 | STANDARD |
Submissions Property Types
CDER Filings
SUN PHARM INDS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 213092
[companyName] => SUN PHARM INDS INC
[docInserts] => ["",""]
[products] => [{"drugName":"LENVATINIB","activeIngredients":"LENVATINIB","strength":"4MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"LENVATINIB","activeIngredients":"LENVATINIB","strength":"10MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"03\/01\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/213092Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-03-01
)
)