ANDA 209488

ZYDUS PHARMS USA INC

FDA Drug Application

Application #209488

Documents

• Letter: 2019-05-21

Application Sponsors

ANDA 209488

ZYDUS PHARMS USA INC

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

2019-04-01

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209488
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIRABEGRON","activeIngredients":"MIRABEGRON","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/01\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209488Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-04-01
        )

)