ANDA 210209

LUPIN LTD

FDA Drug Application

Application #210209

Documents

• Letter: 2018-03-02

Application Sponsors

ANDA 210209

LUPIN LTD

Marketing Status

• Prescription: 001

Application Products

001

LOTION;TOPICAL

0.1%

0

HYDROCORTISONE BUTYRATE

HYDROCORTISONE BUTYRATE

FDA Submissions

MANUF (CMC); Manufacturing (CMC)

ORIG

1

AP

2018-08-17

UNKNOWN

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210209
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCORTISONE BUTYRATE","activeIngredients":"HYDROCORTISONE BUTYRATE","strength":"0.1%","dosageForm":"LOTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/17\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Manufacturing (CMC)","reviewPriority":"UNKNOWN","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210209Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-08-17
        )

)