ANDA 075746

AM REGENT

FDA Drug Application

Application #075746

Application Sponsors

ANDA 075746

AM REGENT

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	0.001MG/ML	0	CALCITRIOL	CALCITRIOL
002	INJECTABLE;INJECTION	0.002MG/ML	0	CALCITRIOL	CALCITRIOL

FDA Submissions

	ORIG	1	AP	2003-09-26
LABELING; Labeling	SUPPL	3	AP	2008-07-06

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75746
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"CALCITRIOL","activeIngredients":"CALCITRIOL","strength":"0.001MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CALCITRIOL","activeIngredients":"CALCITRIOL","strength":"0.002MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CALCITRIOL","submission":"CALCITRIOL","actionType":"0.001MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CALCITRIOL","submission":"CALCITRIOL","actionType":"0.002MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)