HONG KONG FDA Approval ANDA 214507

ANDA 214507

HONG KONG

FDA Drug Application

Application #214507

Application Sponsors

ANDA 214507HONG KONG

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTIONEQ 50MG BASE/ML0HALOPERIDOL DECANOATEHALOPERIDOL DECANOATE
002INJECTABLE;INJECTIONEQ 100MG BASE/ML0HALOPERIDOL DECANOATEHALOPERIDOL DECANOATE

FDA Submissions

UNKNOWN; ORIG1AP2021-07-26STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAO
002PrescriptionAO

CDER Filings

HONG KONG
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214507
            [companyName] => HONG KONG
            [docInserts] => ["",""]
            [products] => [{"drugName":"HALOPERIDOL DECANOATE","activeIngredients":"HALOPERIDOL DECANOATE","strength":"EQ 50MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HALOPERIDOL DECANOATE","activeIngredients":"HALOPERIDOL DECANOATE","strength":"EQ 100MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/26\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-07-26
        )

)

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