ANDA 212933

LUPIN LTD

FDA Drug Application

Application #212933

Application Sponsors

ANDA 212933

LUPIN LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

250MG

0

PENICILLAMINE

PENICILLAMINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-11-30

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212933
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PENICILLAMINE","activeIngredients":"PENICILLAMINE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/30\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-30
        )

)