MANKIND PHARMA FDA Approval ANDA 213614

ANDA 213614

MANKIND PHARMA

FDA Drug Application

Application #213614

Application Sponsors

ANDA 213614MANKIND PHARMA

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORALEQ 0.5MG BASE0ALOSETRON HYDROCHLORIDEALOSETRON HYDROCHLORIDE
002TABLET;ORALEQ 1MG BASE0ALOSETRON HYDROCHLORIDEALOSETRON HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-09-09STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

MANKIND PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213614
            [companyName] => MANKIND PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALOSETRON HYDROCHLORIDE","activeIngredients":"ALOSETRON HYDROCHLORIDE","strength":"EQ 0.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ALOSETRON HYDROCHLORIDE","activeIngredients":"ALOSETRON HYDROCHLORIDE","strength":"EQ 1MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/09\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-09
        )

)

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