ZYDUS PHARMS USA INC FDA Approval ANDA 210204

ANDA 210204

ZYDUS PHARMS USA INC

FDA Drug Application

Application #210204

Application Sponsors

ANDA 210204ZYDUS PHARMS USA INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INTRAVENOUS, SUBCUTANEOUS3.5MG/VIAL0BORTEZOMIBBORTEZOMIB

FDA Submissions

UNKNOWN; ORIG1TA2018-11-29STANDARD

Submissions Property Types

ORIG1Null31

TE Codes

001PrescriptionAP

CDER Filings

ZYDUS PHARMS USA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210204
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BORTEZOMIB","activeIngredients":"BORTEZOMIB","strength":"3.5MG\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/02\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-05-02
        )

)

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