ANDA 211324

CADILA PHARMS LTD

FDA Drug Application

Application #211324

Application Sponsors

ANDA 211324

CADILA PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

60MG

0

RALOXIFENE HYDROCHLORIDE

RALOXIFENE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-08-18

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

CADILA PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211324
            [companyName] => CADILA PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"RALOXIFENE HYDROCHLORIDE","activeIngredients":"RALOXIFENE HYDROCHLORIDE","strength":"60MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/18\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-18
        )

)