HIKMA FDA Approval ANDA 204360

ANDA 204360

HIKMA

FDA Drug Application

Application #204360

Application Sponsors

ANDA 204360HIKMA

Marketing Status

Prescription001
Prescription002

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2018-10-15
LABELING; LabelingSUPPL9AP2021-05-25STANDARD

Submissions Property Types

ORIG1Null15
SUPPL9Null7

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

HIKMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204360
            [companyName] => HIKMA
            [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":"10\/15\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/27\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-08-27
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.