Application Sponsors
ANDA 214319 | SUN PHARM INDS | |
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
Application Products
002 | INJECTABLE;INJECTION | EQ 200MG BASE/2ML (EQ 100MG BASE/ML) | 0 | SUGAMMADEX | SUGAMMADEX |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2022-05-10 | STANDARD |
Submissions Property Types
CDER Filings
SUN PHARM INDS
cder:Array
(
[0] => Array
(
[ApplNo] => 214319
[companyName] => SUN PHARM INDS
[docInserts] => ["",""]
[products] => [{"drugName":"SUGAMMADEX","activeIngredients":"SUGAMMADEX","strength":"EQ 500MG BASE\/5ML (EQ 100MG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SUGAMMADEX","activeIngredients":"SUGAMMADEX","strength":"EQ 200MG BASE\/2ML (EQ 100MG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/10\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-05-10
)
)