ANDA 210148

ACCORD HLTHCARE INC

FDA Drug Application

Application #210148

Application Sponsors

ANDA 210148

ACCORD HLTHCARE INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

6MG/ML

0

BUSULFAN

BUSULFAN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-02-22	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-03-10	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7

TE Codes

001

Prescription

AP

CDER Filings

ACCORD HLTHCARE INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210148
            [companyName] => ACCORD HLTHCARE INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUSULFAN","activeIngredients":"BUSULFAN","strength":"6MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/22\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-02-22
        )

)