HIKMA PHARMS FDA Approval ANDA 204842

ANDA 204842

HIKMA PHARMS

FDA Drug Application

Application #204842

Application Sponsors

ANDA 204842HIKMA PHARMS

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001INJECTABLE;INJECTION0.25%0BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE
002INJECTABLE;INJECTION0.5%0BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE
003INJECTABLE;INJECTION0.75%0BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-02-11STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP
002PrescriptionAP
003PrescriptionAP

CDER Filings

HIKMA PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204842
            [companyName] => HIKMA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE","activeIngredients":"BUPIVACAINE HYDROCHLORIDE","strength":"0.25%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE","activeIngredients":"BUPIVACAINE HYDROCHLORIDE","strength":"0.5%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE","activeIngredients":"BUPIVACAINE HYDROCHLORIDE","strength":"0.75%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/11\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-11
        )

)

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