ANDA 212091

PIRAMAL HLTHCARE UK

FDA Drug Application

Application #212091

Documents

• Letter: 2020-05-19

Application Sponsors

ANDA 212091

PIRAMAL HLTHCARE UK

Marketing Status

• None (Tentative Approval): 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 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

2020-04-24

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

PIRAMAL HLTHCARE UK

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212091
            [companyName] => PIRAMAL HLTHCARE UK
            [docInserts] => ["",""]
            [products] => [{"drugName":"LURASIDONE HYDROCHLORIDE","activeIngredients":"LURASIDONE HYDROCHLORIDE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/24\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212091Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-04-24
        )

)