ANDA 090842

INVAGEN PHARMS

FDA Drug Application

Application #090842

Documents

• Review: 2018-05-22

Application Sponsors

ANDA 090842

INVAGEN PHARMS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

60MG

0

RALOXIFENE HYDROCHLORIDE

RALOXIFENE HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

2014-09-24

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

INVAGEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90842
            [companyName] => INVAGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"RALOXIFENE HYDROCHLORIDE","activeIngredients":"RALOXIFENE HYDROCHLORIDE","strength":"60MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RALOXIFENE HYDROCHLORIDE","submission":"RALOXIFENE HYDROCHLORIDE","actionType":"60MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)