ANDA 209087

B BRAUN MEDICAL INC

FDA Drug Application

Application #209087

Application Sponsors

ANDA 209087

B BRAUN MEDICAL INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;SPINAL

0.75%

0

BUPIVACAINE HYDROCHLORIDE

BUPIVACAINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-04-02

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

B BRAUN MEDICAL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209087
            [companyName] => B BRAUN MEDICAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUPIVACAINE HYDROCHLORIDE","activeIngredients":"BUPIVACAINE HYDROCHLORIDE","strength":"0.75%","dosageForm":"INJECTABLE;SPINAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/02\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-04-02
        )

)