ANDA 212244

ALKEM LABS LTD

FDA Drug Application

Application #212244

Documents

• Letter: 2020-05-15

Application Sponsors

ANDA 212244

ALKEM LABS LTD

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003
• None (Tentative Approval): 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	60MG	0	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE
004	TABLET;ORAL	80MG	0	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE
005	TABLET;ORAL	120MG	0	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-03-09

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212244
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LURASIDONE HYDROCHLORIDE","activeIngredients":"LURASIDONE HYDROCHLORIDE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LURASIDONE HYDROCHLORIDE","activeIngredients":"LURASIDONE HYDROCHLORIDE","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LURASIDONE HYDROCHLORIDE","activeIngredients":"LURASIDONE HYDROCHLORIDE","strength":"60MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LURASIDONE HYDROCHLORIDE","activeIngredients":"LURASIDONE HYDROCHLORIDE","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LURASIDONE HYDROCHLORIDE","activeIngredients":"LURASIDONE HYDROCHLORIDE","strength":"120MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/09\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212244Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-03-09
        )

)