HIKMA FDA Approval ANDA 214074

ANDA 214074

HIKMA

FDA Drug Application

Application #214074

Application Sponsors

ANDA 214074HIKMA

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001SOLUTION;INJECTION40MG/20ML (2MG/ML)0ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE
002SOLUTION;INJECTION150MG/30ML (5MG/ML)0ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE
003SOLUTION;INJECTION150MG/20ML (7.5MG/ML)0ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE
004SOLUTION;INJECTION200MG/20ML (10MG/ML)0ROPIVACAINE HYDROCHLORIDEROPIVACAINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-07-20STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP
002PrescriptionAP
003PrescriptionAP
004PrescriptionAP

CDER Filings

HIKMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214074
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ROPIVACAINE HYDROCHLORIDE","activeIngredients":"ROPIVACAINE HYDROCHLORIDE","strength":"40MG\/20ML (2MG\/ML)","dosageForm":"SOLUTION;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROPIVACAINE HYDROCHLORIDE","activeIngredients":"ROPIVACAINE HYDROCHLORIDE","strength":"150MG\/30ML (5MG\/ML)","dosageForm":"SOLUTION;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROPIVACAINE HYDROCHLORIDE","activeIngredients":"ROPIVACAINE HYDROCHLORIDE","strength":"150MG\/20ML (7.5MG\/ML)","dosageForm":"SOLUTION;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROPIVACAINE HYDROCHLORIDE","activeIngredients":"ROPIVACAINE HYDROCHLORIDE","strength":"200MG\/20ML (10MG\/ML)","dosageForm":"SOLUTION;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/20\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-20
        )

)

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