ZYDUS FDA Approval ANDA 212299

ANDA 212299

ZYDUS

FDA Drug Application

Application #212299

Application Sponsors

ANDA 212299ZYDUS

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE, LIPOSOMAL;INJECTION20MG/10ML (2MG/ML)0DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDE
002INJECTABLE, LIPOSOMAL;INJECTION50MG/25ML (2MG/ML)0DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-09-10STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

ZYDUS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212299
            [companyName] => ZYDUS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXORUBICIN HYDROCHLORIDE","activeIngredients":"DOXORUBICIN HYDROCHLORIDE","strength":"20MG\/10ML (2MG\/ML)","dosageForm":"INJECTABLE, LIPOSOMAL;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXORUBICIN HYDROCHLORIDE","activeIngredients":"DOXORUBICIN HYDROCHLORIDE","strength":"50MG\/25ML (2MG\/ML)","dosageForm":"INJECTABLE, LIPOSOMAL;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/10\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-10
        )

)

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