ANDA 210307

LUPIN LTD

FDA Drug Application

Application #210307

Application Sponsors

ANDA 210307

LUPIN LTD

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

0.2%

0

HYDROCORTISONE VALERATE

HYDROCORTISONE VALERATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-08-15

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210307
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCORTISONE VALERATE","activeIngredients":"HYDROCORTISONE VALERATE","strength":"0.2%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/15\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-08-15
        )

)