ANDA 208120

MYLAN

FDA Drug Application

Application #208120

Application Sponsors

ANDA 208120

MYLAN

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 100MG BASE/ML

0

VALPROATE SODIUM

VALPROATE SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-12-22

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

MYLAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208120
            [companyName] => MYLAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"VALPROATE SODIUM","activeIngredients":"VALPROATE SODIUM","strength":"EQ 100MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/22\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-12-22
        )

)