HIKMA FDA Approval ANDA 091433

ANDA 091433

HIKMA

FDA Drug Application

Application #091433

Documents

Letter2011-11-07

Application Sponsors

ANDA 091433HIKMA

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE;ORAL0.5MCG0DOXERCALCIFEROLDOXERCALCIFEROL
002CAPSULE;ORAL1MCG0DOXERCALCIFEROLDOXERCALCIFEROL
003CAPSULE;ORAL2.5MCG0DOXERCALCIFEROLDOXERCALCIFEROL

FDA Submissions

ORIG1AP2011-09-23
ORIG2AP2014-01-14
LABELING; LabelingSUPPL7AP2020-10-13STANDARD

Submissions Property Types

ORIG1Null15
ORIG2Null19
SUPPL7Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

HIKMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91433
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXERCALCIFEROL","activeIngredients":"DOXERCALCIFEROL","strength":"0.5MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXERCALCIFEROL","activeIngredients":"DOXERCALCIFEROL","strength":"1MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXERCALCIFEROL","activeIngredients":"DOXERCALCIFEROL","strength":"2.5MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DOXERCALCIFEROL","submission":"DOXERCALCIFEROL","actionType":"0.5MCG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DOXERCALCIFEROL","submission":"DOXERCALCIFEROL","actionType":"1MCG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DOXERCALCIFEROL","submission":"DOXERCALCIFEROL","actionType":"2.5MCG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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