NANJING KING-FRIEND FDA Approval ANDA 212129

ANDA 212129

NANJING KING-FRIEND

FDA Drug Application

Application #212129

Application Sponsors

ANDA 212129NANJING KING-FRIEND

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001INJECTABLE;INJECTION200MG/5.26ML (38MG/ML)0GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDE
002INJECTABLE;INJECTION1GM/26.3ML (38MG/ML)0GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDE
003INJECTABLE;INJECTION2GM/52.6ML (38MG/ML)0GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-12-11STANDARD

Submissions Property Types

ORIG1Null31

TE Codes

001PrescriptionAP
002PrescriptionAP
003PrescriptionAP

CDER Filings

NANJING KING-FRIEND
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212129
            [companyName] => NANJING KING-FRIEND
            [docInserts] => ["",""]
            [products] => [{"drugName":"GEMCITABINE HYDROCHLORIDE","activeIngredients":"GEMCITABINE HYDROCHLORIDE","strength":"200MG\/5.26ML (38MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GEMCITABINE HYDROCHLORIDE","activeIngredients":"GEMCITABINE HYDROCHLORIDE","strength":"1GM\/26.3ML (38MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GEMCITABINE HYDROCHLORIDE","activeIngredients":"GEMCITABINE HYDROCHLORIDE","strength":"2GM\/52.6ML (38MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/11\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-11
        )

)

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