NANJING KING-FRIEND FDA Approval ANDA 215197

ANDA 215197

NANJING KING-FRIEND

FDA Drug Application

Application #215197

Documents

Letter2022-08-01

Application Sponsors

ANDA 215197NANJING KING-FRIEND

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTIONEQ 500MG BASE/VIAL0VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDE
002INJECTABLE;INJECTIONEQ 1GM BASE/VIAL0VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1TA2021-08-20STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

NANJING KING-FRIEND
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215197
            [companyName] => NANJING KING-FRIEND
            [docInserts] => ["",""]
            [products] => [{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/20\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215197Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-20
        )

)

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.