ANDA 211633

LUPIN LTD

FDA Drug Application

Application #211633

Application Sponsors

ANDA 211633

LUPIN LTD

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

100MG EXTENDED

0

EXTENDED PHENYTOIN SODIUM

PHENYTOIN SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-09-30

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211633
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"EXTENDED PHENYTOIN SODIUM","activeIngredients":"PHENYTOIN SODIUM","strength":"100MG EXTENDED","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/30\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-09-30
        )

)