HIKMA FDA Approval ANDA 210732

ANDA 210732

HIKMA

FDA Drug Application

Application #210732

Application Sponsors

ANDA 210732HIKMA

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001CAPSULE, EXTENDED RELEASE;ORALEQ 20MG BASE0LEVOMILNACIPRAN HYDROCHLORIDELEVOMILNACIPRAN HYDROCHLORIDE
002CAPSULE, EXTENDED RELEASE;ORALEQ 40MG BASE0LEVOMILNACIPRAN HYDROCHLORIDELEVOMILNACIPRAN HYDROCHLORIDE
003CAPSULE, EXTENDED RELEASE;ORALEQ 80MG BASE0LEVOMILNACIPRAN HYDROCHLORIDELEVOMILNACIPRAN HYDROCHLORIDE
004CAPSULE, EXTENDED RELEASE;ORALEQ 120MG BASE0LEVOMILNACIPRAN HYDROCHLORIDELEVOMILNACIPRAN HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-11-05STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

HIKMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210732
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOMILNACIPRAN HYDROCHLORIDE","activeIngredients":"LEVOMILNACIPRAN HYDROCHLORIDE","strength":"EQ 20MG BASE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOMILNACIPRAN HYDROCHLORIDE","activeIngredients":"LEVOMILNACIPRAN HYDROCHLORIDE","strength":"EQ 40MG BASE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOMILNACIPRAN HYDROCHLORIDE","activeIngredients":"LEVOMILNACIPRAN HYDROCHLORIDE","strength":"EQ 80MG BASE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOMILNACIPRAN HYDROCHLORIDE","activeIngredients":"LEVOMILNACIPRAN HYDROCHLORIDE","strength":"EQ 120MG BASE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/05\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-05
        )

)

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