ANDA 209485

LUPIN LTD

FDA Drug Application

Application #209485

Documents

• Letter: 2019-07-05

Application Sponsors

ANDA 209485

LUPIN LTD

Marketing Status

• None (Tentative Approval): 001
• Prescription: 002

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	25MG	0	MIRABEGRON	MIRABEGRON
002	TABLET, EXTENDED RELEASE;ORAL	50MG	0	MIRABEGRON	MIRABEGRON

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-06-26

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209485
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIRABEGRON","activeIngredients":"MIRABEGRON","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/26\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209485Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-06-26
        )

)