Almatica Pharma, LLC FDA Approval NDA 214826

NDA 214826

Almatica Pharma, LLC

FDA Drug Application

Application #214826

Documents

Letter2021-08-31

Application Sponsors

NDA 214826Almatica Pharma, LLC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE, EXTENDED RELEASE;ORAL1MG0LOREEV XRLORAZEPAM
002CAPSULE, EXTENDED RELEASE;ORAL2MG0LOREEV XRLORAZEPAM
003CAPSULE, EXTENDED RELEASE; ORAL3MG0LOREEV XRLORAZEPAM

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2021-08-27STANDARD

Submissions Property Types

ORIG1Null15

CDER Filings

Almatica Pharma, LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214826
            [companyName] => Almatica Pharma, LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOREEV XR","activeIngredients":"LORAZEPAM","strength":"1MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"LOREEV XR","activeIngredients":"LORAZEPAM","strength":"2MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"LOREEV XR","activeIngredients":"LORAZEPAM","strength":"3MG","dosageForm":"CAPSULE, EXTENDED RELEASE; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/27\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214826Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-27
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.