ANDA 213236

ACCORD HLTHCARE

FDA Drug Application

Application #213236

Application Sponsors

ANDA 213236

ACCORD HLTHCARE

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

0.4MG/5ML (0.08MG/ML)

0

REGADENOSON

REGADENOSON

FDA Submissions

UNKNOWN;	ORIG	1	AP	2022-04-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2022-08-02	UNKNOWN

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

TE Codes

001

Prescription

AP

CDER Filings

ACCORD HLTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213236
            [companyName] => ACCORD HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"REGADENOSON","activeIngredients":"REGADENOSON","strength":"0.4MG\/5ML (0.08MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/11\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-04-11
        )

)