Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | EQ 2MG BASE/ML | 0 | CISATRACURIUM BESYLATE PRESERVATIVE FREE | CISATRACURIUM BESYLATE |
| 002 | INJECTABLE;INJECTION | EQ 10MG BASE/ML | 0 | CISATRACURIUM BESYLATE PRESERVATIVE FREE | CISATRACURIUM BESYLATE |
FDA Submissions
| ORIG | 1 | AP | 2012-02-03 | |
| LABELING; Labeling | SUPPL | 8 | AP | 2017-12-27 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2020-07-23 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 9 | Null | 15 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
SANDOZ INC
cder:Array
(
[0] => Array
(
[ApplNo] => 200154
[companyName] => SANDOZ INC
[docInserts] => ["",""]
[products] => [{"drugName":"CISATRACURIUM BESYLATE PRESERVATIVE FREE","activeIngredients":"CISATRACURIUM BESYLATE","strength":"EQ 2MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CISATRACURIUM BESYLATE PRESERVATIVE FREE","activeIngredients":"CISATRACURIUM BESYLATE","strength":"EQ 10MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"02\/03\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/2012\\\/200154Orig1s000Approv.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"12\/27\/2017","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2017-12-27
)
)