Application Sponsors
ANDA 201836 | SAGENT PHARMS INC | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | INJECTABLE;INJECTION | EQ 2MG BASE/ML | 0 | CISATRACURIUM BESYLATE | CISATRACURIUM BESYLATE |
002 | INJECTABLE;INJECTION | EQ 10MG BASE/ML | 0 | CISATRACURIUM BESYLATE | CISATRACURIUM BESYLATE |
FDA Submissions
Submissions Property Types
TE Codes
001 | Prescription | AP |
002 | Prescription | AP |
CDER Filings
SAGENT PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 201836
[companyName] => SAGENT PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"CISATRACURIUM BESYLATE","activeIngredients":"CISATRACURIUM BESYLATE","strength":"EQ 2MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CISATRACURIUM BESYLATE","activeIngredients":"CISATRACURIUM BESYLATE","strength":"EQ 10MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"11\/06\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-11-06
)
)