ANDA 209330

BRECKENRIDGE

FDA Drug Application

Application #209330

Documents

• Letter: 2021-07-07

Application Sponsors

ANDA 209330

BRECKENRIDGE

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	POWDER;INTRAVENOUS	10MG/VIAL	0	CARFILZOMIB	CARFILZOMIB
002	POWDER;INTRAVENOUS	60MG/VIAL	0	CARFILZOMIB	CARFILZOMIB

FDA Submissions

UNKNOWN;	ORIG	1	AP	2021-06-11	STANDARD
UNKNOWN;	ORIG	2	TA	2021-06-11	STANDARD

Submissions Property Types

ORIG	1	Null	7
ORIG	2	Null	31

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

BRECKENRIDGE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209330
            [companyName] => BRECKENRIDGE
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARFILZOMIB","activeIngredients":"CARFILZOMIB","strength":"10MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARFILZOMIB","activeIngredients":"CARFILZOMIB","strength":"60MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/11\/2021","submission":"ORIG-2","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/11\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-11
        )

)