ANDA 208727

AUROBINDO PHARMA LTD

FDA Drug Application

Application #208727

Application Sponsors

ANDA 208727

AUROBINDO PHARMA LTD

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

UNKNOWN;	ORIG	1	AP	2016-12-15	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-04-13	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208727
            [companyName] => AUROBINDO PHARMA LTD
            [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":"12\/15\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/13\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-04-13
        )

)