CIPLA FDA Approval ANDA 210855

ANDA 210855

CIPLA

FDA Drug Application

Application #210855

Application Sponsors

ANDA 210855CIPLA

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION25MG/ML0SODIUM NITROPRUSSIDESODIUM NITROPRUSSIDE

FDA Submissions

UNKNOWN; ORIG1AP2018-07-16STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

CIPLA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210855
            [companyName] => CIPLA
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM NITROPRUSSIDE","activeIngredients":"SODIUM NITROPRUSSIDE","strength":"25MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/16\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-07-16
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.