ANDA 208474

B BRAUN MEDICAL INC

FDA Drug Application

Application #208474

Application Sponsors

ANDA 208474

B BRAUN MEDICAL INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

1%

0

LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-08-03

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

B BRAUN MEDICAL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208474
            [companyName] => B BRAUN MEDICAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIDOCAINE HYDROCHLORIDE","activeIngredients":"LIDOCAINE HYDROCHLORIDE","strength":"1%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/03\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/29\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-29
        )

)