ANDA 208055

TORRENT

FDA Drug Application

Application #208055

Documents

• Letter: 2018-10-15

Application Sponsors

ANDA 208055

TORRENT

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004
• None (Tentative Approval): 005

Application Products

001	TABLET;ORAL	20MG	0	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE
002	TABLET;ORAL	40MG	0	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE
003	TABLET;ORAL	80MG	0	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE
004	TABLET;ORAL	120MG	0	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-01-03	STANDARD
UNKNOWN;	ORIG	2	TA	2019-01-03	STANDARD

Submissions Property Types

ORIG	1	Null	15
ORIG	2	Null	31

CDER Filings

TORRENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208055
            [companyName] => TORRENT
            [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":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LURASIDONE HYDROCHLORIDE","activeIngredients":"LURASIDONE HYDROCHLORIDE","strength":"120MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LURASIDONE HYDROCHLORIDE","activeIngredients":"LURASIDONE HYDROCHLORIDE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/03\/2019","submission":"ORIG-2","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/03\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208055Orig1s000TALtr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-01-03
        )

)