ANDA 205150

INVENTIA

FDA Drug Application

Application #205150

Application Sponsors

ANDA 205150

INVENTIA

Marketing Status

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

Application Products

001	TABLET;ORAL	20MG	0	TELMISARTAN	TELMISARTAN
002	TABLET;ORAL	40MG	0	TELMISARTAN	TELMISARTAN
003	TABLET;ORAL	80MG	0	TELMISARTAN	TELMISARTAN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-10-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2017-06-28	UNKNOWN
LABELING; Labeling	SUPPL	5	AP	2019-07-09	STANDARD
LABELING; Labeling	SUPPL	7	AP	2019-07-09	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	7
SUPPL	5	Null	7
SUPPL	7	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

INVENTIA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205150
            [companyName] => INVENTIA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TELMISARTAN","activeIngredients":"TELMISARTAN","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TELMISARTAN","activeIngredients":"TELMISARTAN","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TELMISARTAN","activeIngredients":"TELMISARTAN","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/30\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/09\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/09\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/28\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/24\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-07-09
        )

)