NDA 214439

CMP DEV LLC

FDA Drug Application

Application #214439

Documents

• Letter: 2022-02-28
• Label: 2022-02-28
• Review: 2022-10-17

Application Sponsors

NDA 214439

CMP DEV LLC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION; ORAL

1MG/1ML

0

NORLIQVA

AMLODIPINE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2022-02-24

STANDARD

Submissions Property Types

ORIG

1

Null

40

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
        )

)