HONG KONG FDA Approval ANDA 213460

ANDA 213460

HONG KONG

FDA Drug Application

Application #213460

Application Sponsors

ANDA 213460HONG KONG

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION100MG/VIAL0CARMUSTINECARMUSTINE

FDA Submissions

UNKNOWN; ORIG1AP2021-08-02STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

HONG KONG
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213460
            [companyName] => HONG KONG
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARMUSTINE","activeIngredients":"CARMUSTINE","strength":"100MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/02\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-02
        )

)

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