ANDA 207604

APOTEX INC

FDA Drug Application

Application #207604

Documents

• Letter: 2022-08-26

Application Sponsors

ANDA 207604

APOTEX INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SOLUTION;INTRAVENOUS

0.4MG/5ML (0.08MG/ML)

0

REGADENOSON

REGADENOSON

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-05-27

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AP

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207604
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"REGADENOSON","activeIngredients":"REGADENOSON","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/27\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-27
        )

)