CMP DEV LLC FDA Approval NDA 214439

NDA 214439

CMP DEV LLC

FDA Drug Application

Application #214439

Documents

Letter2022-02-28
Label2022-02-28

Application Sponsors

NDA 214439CMP DEV LLC

Marketing Status

Prescription001

Application Products

001SOLUTION; ORAL1MG/1ML0NORLIQVAAMLODIPINE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2022-02-24STANDARD

Submissions Property Types

ORIG1Null40

CDER Filings

CMP DEV LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214439
            [companyName] => CMP DEV LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NORLIQVA","activeIngredients":"AMLODIPINE","strength":"1MG\/1ML","dosageForm":"SOLUTION; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"02\/24\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/214439s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/24\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/214439s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/214439Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-02-24
        )

)

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