Application Sponsors
Marketing Status
Application Products
| 001 | INJECTABLE;INJECTION | EQ 2MG BASE/ML | 0 | CISATRACURIUM BESYLATE | CISATRACURIUM BESYLATE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2018-03-30 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2020-05-29 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2020-05-29 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 5 | Null | 7 |
TE Codes
CDER Filings
HOSPIRA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 203238
[companyName] => HOSPIRA INC
[docInserts] => ["",""]
[products] => [{"drugName":"CISATRACURIUM BESYLATE","activeIngredients":"CISATRACURIUM BESYLATE","strength":"EQ 2MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"03\/30\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"05\/29\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/29\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/29\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-05-29
)
)