ANDA 201192

TORRENT

FDA Drug Application

Application #201192

Documents

• Letter: 2014-02-27

Application Sponsors

ANDA 201192

TORRENT

Marketing Status

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

Application Products

001	TABLET;ORAL	12.5MG;40MG	0	TELMISARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TELMISARTAN
002	TABLET;ORAL	12.5MG;80MG	0	TELMISARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TELMISARTAN
003	TABLET;ORAL	25MG;80MG	0	TELMISARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TELMISARTAN

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2014-02-25
LABELING; Labeling	SUPPL	2	AP	2016-03-24	STANDARD
LABELING; Labeling	SUPPL	3	AP	2016-03-24	STANDARD
LABELING; Labeling	SUPPL	6	AP	2019-11-06	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	2	Null	15
SUPPL	3	Null	7
SUPPL	6	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

TORRENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201192
            [companyName] => TORRENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"TELMISARTAN AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; TELMISARTAN","strength":"12.5MG;40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TELMISARTAN AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; TELMISARTAN","strength":"12.5MG;80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TELMISARTAN AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; TELMISARTAN","strength":"25MG;80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/25\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/201192Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/06\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/24\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/24\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-11-06
        )

)