ANDA 091101

HIKMA PHARMS

FDA Drug Application

Application #091101

Documents

• Letter: 2013-09-04

Application Sponsors

ANDA 091101

HIKMA PHARMS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

4MCG/2ML (2MCG/ML)

0

DOXERCALCIFEROL

DOXERCALCIFEROL

FDA Submissions

ORIG

1

AP

2013-08-30

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91101
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXERCALCIFEROL","activeIngredients":"DOXERCALCIFEROL","strength":"4MCG\/2ML (2MCG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DOXERCALCIFEROL","submission":"DOXERCALCIFEROL","actionType":"4MCG\/2ML (2MCG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)