ANDA 205960

BRECKENRIDGE

FDA Drug Application

Application #205960

Documents

• Letter: 2021-01-07

Application Sponsors

ANDA 205960

BRECKENRIDGE

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;SUBLINGUAL	EQ 2.5MG BASE	0	ASENAPINE MALEATE	ASENAPINE MALEATE
002	TABLET;SUBLINGUAL	EQ 10MG BASE	0	ASENAPINE MALEATE	ASENAPINE MALEATE
003	TABLET;SUBLINGUAL	EQ 5MG BASE	0	ASENAPINE MALEATE	ASENAPINE MALEATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-12-10	STANDARD
UNKNOWN;	ORIG	2	TA	2020-12-10	STANDARD

Submissions Property Types

ORIG	1	Null	15
ORIG	2	Null	31

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

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
        )

)