ANDA 207148

WOCKHARDT BIO AG

FDA Drug Application

Application #207148

Application Sponsors

ANDA 207148

WOCKHARDT BIO AG

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 10GM BASE/VIAL

0

OXACILLIN SODIUM

OXACILLIN SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-11-24

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

WOCKHARDT BIO AG

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207148
            [companyName] => WOCKHARDT BIO AG
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXACILLIN SODIUM","activeIngredients":"OXACILLIN SODIUM","strength":"EQ 10GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/24\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-11-24
        )

)