ANDA 208827

B BRAUN MEDICAL INC

FDA Drug Application

Application #208827

Application Sponsors

ANDA 208827

B BRAUN MEDICAL INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

5,000 UNITS/0.5ML

0

HEPARIN SODIUM

HEPARIN SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-11-19

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

B BRAUN MEDICAL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208827
            [companyName] => B BRAUN MEDICAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HEPARIN SODIUM","activeIngredients":"HEPARIN SODIUM","strength":"5,000 UNITS\/0.5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/19\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-11-19
        )

)