ANDA 203867

SANDOZ INC

FDA Drug Application

Application #203867

Application Sponsors

ANDA 203867

SANDOZ INC

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	2014-11-03
LABELING; Labeling	SUPPL	2	AP	2015-11-17	STANDARD
LABELING; Labeling	SUPPL	4	AP	2015-11-17	STANDARD
LABELING; Labeling	SUPPL	7	AP	2019-05-17	STANDARD

Submissions Property Types

ORIG	1	Null	17
SUPPL	2	Null	7
SUPPL	4	Null	7
SUPPL	7	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203867
            [companyName] => SANDOZ INC
            [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":"11\/03\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/17\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/17\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/17\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-05-17
        )

)