ZYDUS PHARMS FDA Approval ANDA 214215

ANDA 214215

ZYDUS PHARMS

FDA Drug Application

Application #214215

Application Sponsors

ANDA 214215ZYDUS PHARMS

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION2.5MG/ML0VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-10-15STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

ZYDUS PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214215
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"VERAPAMIL HYDROCHLORIDE","activeIngredients":"VERAPAMIL HYDROCHLORIDE","strength":"2.5MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/15\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-15
        )

)

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.