ANDA 208643

LUPIN LTD

FDA Drug Application

Application #208643

Application Sponsors

ANDA 208643

LUPIN LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	1.5MG	0	PALIPERIDONE	PALIPERIDONE
002	TABLET, EXTENDED RELEASE;ORAL	3MG	0	PALIPERIDONE	PALIPERIDONE
003	TABLET, EXTENDED RELEASE;ORAL	6MG	0	PALIPERIDONE	PALIPERIDONE
004	TABLET, EXTENDED RELEASE;ORAL	9MG	0	PALIPERIDONE	PALIPERIDONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-06-29

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

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

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208643
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PALIPERIDONE","activeIngredients":"PALIPERIDONE","strength":"1.5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PALIPERIDONE","activeIngredients":"PALIPERIDONE","strength":"3MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PALIPERIDONE","activeIngredients":"PALIPERIDONE","strength":"6MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PALIPERIDONE","activeIngredients":"PALIPERIDONE","strength":"9MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/29\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-06-29
        )

)