ANDA 213834

UNICHEM

FDA Drug Application

Application #213834

Application Sponsors

ANDA 213834

UNICHEM

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

100MG EXTENDED

0

EXTENDED PHENYTOIN SODIUM

PHENYTOIN SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-10-13

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

UNICHEM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213834
            [companyName] => UNICHEM
            [docInserts] => ["",""]
            [products] => [{"drugName":"EXTENDED PHENYTOIN SODIUM","activeIngredients":"PHENYTOIN SODIUM","strength":"100MG EXTENDED","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/13\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-13
        )

)