ANDA 202544

GLENMARK PHARMS LTD

FDA Drug Application

Application #202544

Application Sponsors

ANDA 202544

GLENMARK PHARMS 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	2019-03-04
LABELING; Labeling	SUPPL	2	AP	2022-01-24	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

GLENMARK PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202544
            [companyName] => GLENMARK PHARMS 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":"03\/04\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-03-04
        )

)