MICRO LABS FDA Approval ANDA 211370

ANDA 211370

MICRO LABS

FDA Drug Application

Application #211370

Application Sponsors

ANDA 211370MICRO LABS

Marketing Status

Prescription001
Prescription002

Application Products

001SOLUTION;INTRAVENOUS5MG/2ML (2.5MG/ML)0VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDE
002SOLUTION;INTRAVENOUS10MG/4ML (2.5MG/ML)0VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2018-12-28STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

MICRO LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211370
            [companyName] => MICRO LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"VERAPAMIL HYDROCHLORIDE","activeIngredients":"VERAPAMIL HYDROCHLORIDE","strength":"5MG\/2ML (2.5MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VERAPAMIL HYDROCHLORIDE","activeIngredients":"VERAPAMIL HYDROCHLORIDE","strength":"10MG\/4ML (2.5MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/28\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/14\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-05-14
        )

)

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