NANJING KING-FRIEND FDA Approval ANDA 211005

ANDA 211005

NANJING KING-FRIEND

FDA Drug Application

Application #211005

Application Sponsors

ANDA 211005NANJING KING-FRIEND

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION1,000 UNITS/ML0HEPARIN SODIUMHEPARIN SODIUM

FDA Submissions

UNKNOWN; ORIG1AP2018-12-14STANDARD
LABELING; LabelingSUPPL3AP2020-09-29STANDARD
LABELING; LabelingSUPPL4AP2021-10-25STANDARD

Submissions Property Types

ORIG1Null15
SUPPL3Null15
SUPPL4Null7

TE Codes

001PrescriptionAP

CDER Filings

NANJING KING-FRIEND
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211005
            [companyName] => NANJING KING-FRIEND
            [docInserts] => ["",""]
            [products] => [{"drugName":"HEPARIN SODIUM","activeIngredients":"HEPARIN SODIUM","strength":"1,000 UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/14\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-12-14
        )

)

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