ANDA 210204

ZYDUS PHARMS USA INC

FDA Drug Application

Application #210204

Application Sponsors

ANDA 210204

ZYDUS PHARMS USA INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS, SUBCUTANEOUS

3.5MG/VIAL

0

BORTEZOMIB

BORTEZOMIB

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-11-29

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AP

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
        )

)