ANDA 208058

EMCURE PHARMS LTD

FDA Drug Application

Application #208058

Documents

• Letter: 2019-05-21

Application Sponsors

ANDA 208058

EMCURE PHARMS LTD

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004

Application Products

001	TABLET;ORAL	20MG	0	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE
002	TABLET;ORAL	40MG	0	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE
003	TABLET;ORAL	60MG	0	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE
004	TABLET;ORAL	80MG	0	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-09-04

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

EMCURE PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208058
            [companyName] => EMCURE PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LURASIDONE HYDROCHLORIDE","activeIngredients":"LURASIDONE HYDROCHLORIDE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LURASIDONE HYDROCHLORIDE","activeIngredients":"LURASIDONE HYDROCHLORIDE","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LURASIDONE HYDROCHLORIDE","activeIngredients":"LURASIDONE HYDROCHLORIDE","strength":"60MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LURASIDONE HYDROCHLORIDE","activeIngredients":"LURASIDONE HYDROCHLORIDE","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/04\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/208058Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-09-04
        )

)