NANG KUANG PHARM CO FDA Approval ANDA 206554

ANDA 206554

NANG KUANG PHARM CO

FDA Drug Application

Application #206554

Application Sponsors

ANDA 206554NANG KUANG PHARM CO

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002

Application Products

002POWDER;IV (INFUSION)100MG/VIAL0BENDAMUSTINE HYDROCHLORIDEBENDAMUSTINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1TA2021-01-26STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

NANG KUANG PHARM CO
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206554
            [companyName] => NANG KUANG PHARM CO
            [docInserts] => ["",""]
            [products] => [{"drugName":"BENDAMUSTINE HYDROCHLORIDE","activeIngredients":"BENDAMUSTINE HYDROCHLORIDE","strength":"25MG\/VIAL","dosageForm":"POWDER;IV (INFUSION)","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BENDAMUSTINE HYDROCHLORIDE","activeIngredients":"BENDAMUSTINE HYDROCHLORIDE","strength":"100MG\/VIAL","dosageForm":"POWDER;IV (INFUSION)","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/26\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-01-26
        )

)

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