ANDA 208047

DR REDDYS LABS LTD

FDA Drug Application

Application #208047

Application Sponsors

ANDA 208047

DR REDDYS LABS LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 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

2021-08-24

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

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

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208047
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LURASIDONE HYDROCHLORIDE","activeIngredients":"LURASIDONE HYDROCHLORIDE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LURASIDONE HYDROCHLORIDE","activeIngredients":"LURASIDONE HYDROCHLORIDE","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LURASIDONE HYDROCHLORIDE","activeIngredients":"LURASIDONE HYDROCHLORIDE","strength":"60MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LURASIDONE HYDROCHLORIDE","activeIngredients":"LURASIDONE HYDROCHLORIDE","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/24\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-24
        )

)