ANDA 210801

LUPIN LTD

FDA Drug Application

Application #210801

Application Sponsors

ANDA 210801

LUPIN LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

4MCG/2ML (2MCG/ML)

0

DOXERCALCIFEROL

DOXERCALCIFEROL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-11-01

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210801
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXERCALCIFEROL","activeIngredients":"DOXERCALCIFEROL","strength":"4MCG\/2ML (2MCG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/01\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-11-01
        )

)