ANDA 200825

WATSON LABS INC

FDA Drug Application

Application #200825

Application Sponsors

ANDA 200825

WATSON LABS INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

60MG

0

RALOXIFENE HYDROCHLORIDE

RALOXIFENE HYDROCHLORIDE

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2015-01-21

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

WATSON LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200825
            [companyName] => WATSON LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"RALOXIFENE HYDROCHLORIDE","activeIngredients":"RALOXIFENE HYDROCHLORIDE","strength":"60MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/21\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-01-21
        )

)