ANDA 207231

INVENTIA

FDA Drug Application

Application #207231

Documents

• Letter: 2016-11-30

Application Sponsors

ANDA 207231

INVENTIA

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004
• Discontinued: 005
• Discontinued: 006
• Discontinued: 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	2016-11-28	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-09-11	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

CDER Filings

INVENTIA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207231
            [companyName] => INVENTIA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ILOPERIDONE","activeIngredients":"ILOPERIDONE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ILOPERIDONE","activeIngredients":"ILOPERIDONE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ILOPERIDONE","activeIngredients":"ILOPERIDONE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ILOPERIDONE","activeIngredients":"ILOPERIDONE","strength":"6MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ILOPERIDONE","activeIngredients":"ILOPERIDONE","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ILOPERIDONE","activeIngredients":"ILOPERIDONE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ILOPERIDONE","activeIngredients":"ILOPERIDONE","strength":"12MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/28\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/207231Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/27\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-01-27
        )

)