HAINAN POLY FDA Approval ANDA 215821

ANDA 215821

HAINAN POLY

FDA Drug Application

Application #215821

Application Sponsors

ANDA 215821HAINAN POLY

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTIONEQ 5GM BASE/VIAL0VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDE
002INJECTABLE;INJECTIONEQ 10GM BASE/VIAL0VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-11-18STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

HAINAN POLY
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215821
            [companyName] => HAINAN POLY
            [docInserts] => ["",""]
            [products] => [{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"EQ 5GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"EQ 10GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/18\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-11-18
        )

)

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