BRECKENRIDGE FDA Approval ANDA 205960

ANDA 205960

BRECKENRIDGE

FDA Drug Application

Application #205960

Documents

Letter2021-01-07

Application Sponsors

ANDA 205960BRECKENRIDGE

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;SUBLINGUALEQ 2.5MG BASE0ASENAPINE MALEATEASENAPINE MALEATE
002TABLET;SUBLINGUALEQ 10MG BASE0ASENAPINE MALEATEASENAPINE MALEATE

FDA Submissions

UNKNOWN; ORIG1AP2020-12-10STANDARD
UNKNOWN; ORIG2TA2020-12-10STANDARD

Submissions Property Types

ORIG1Null15
ORIG2Null31

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

BRECKENRIDGE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205960
            [companyName] => BRECKENRIDGE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ASENAPINE MALEATE","activeIngredients":"ASENAPINE MALEATE","strength":"EQ 2.5MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ASENAPINE MALEATE","activeIngredients":"ASENAPINE MALEATE","strength":"EQ 10MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/10\/2020","submission":"ORIG-2","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/10\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-10
        )

)

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