ANDA 206890

LUPIN LTD

FDA Drug Application

Application #206890

Application Sponsors

ANDA 206890

LUPIN LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006
• Prescription: 007

Application Products

001	TABLET;ORAL	1MG	0	ILOPERIDONE	ILOPERIDONE
002	TABLET;ORAL	2MG	0	ILOPERIDONE	ILOPERIDONE
003	TABLET;ORAL	4MG	0	ILOPERIDONE	ILOPERIDONE
004	TABLET;ORAL	6MG	0	ILOPERIDONE	ILOPERIDONE
005	TABLET;ORAL	8MG	0	ILOPERIDONE	ILOPERIDONE
006	TABLET;ORAL	10MG	0	ILOPERIDONE	ILOPERIDONE
007	TABLET;ORAL	12MG	0	ILOPERIDONE	ILOPERIDONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-05-05

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB
006	Prescription	AB
007	Prescription	AB

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206890
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ILOPERIDONE","activeIngredients":"ILOPERIDONE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ILOPERIDONE","activeIngredients":"ILOPERIDONE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ILOPERIDONE","activeIngredients":"ILOPERIDONE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ILOPERIDONE","activeIngredients":"ILOPERIDONE","strength":"6MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ILOPERIDONE","activeIngredients":"ILOPERIDONE","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ILOPERIDONE","activeIngredients":"ILOPERIDONE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ILOPERIDONE","activeIngredients":"ILOPERIDONE","strength":"12MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/05\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-05-05
        )

)