ANDA 090845

AM REGENT

FDA Drug Application

Application #090845

Application Sponsors

ANDA 090845

AM REGENT

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

50MG/ML

0

PROGESTERONE

PROGESTERONE

FDA Submissions

ORIG

1

AP

2009-06-22

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90845
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROGESTERONE","activeIngredients":"PROGESTERONE","strength":"50MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROGESTERONE","submission":"PROGESTERONE","actionType":"50MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)