Application Sponsors
ANDA 214230 | MANKIND PHARMA | |
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2023-01-20 | STANDARD |
Submissions Property Types
CDER Filings
MANKIND PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 214230
[companyName] => MANKIND PHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"SUGAMMADEX","activeIngredients":"SUGAMMADEX","strength":"200MG\/2ML(100MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SUGAMMADEX","activeIngredients":"SUGAMMADEX","strength":"500MG\/5ML(100MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/20\/2023","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2023-01-20
)
)