ANDA 213527

ZYDUS PHARMS

FDA Drug Application

Application #213527

Application Sponsors

ANDA 213527

ZYDUS PHARMS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 2MG BASE/ML

0

CISATRACURIUM BESYLATE

CISATRACURIUM BESYLATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-09-01

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

ZYDUS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213527
            [companyName] => ZYDUS PHARMS
            [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":"09\/01\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-01
        )

)