ANDA 208847

UMEDICA LABS PVT LTD

FDA Drug Application

Application #208847

Application Sponsors

ANDA 208847

UMEDICA LABS PVT LTD

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET;ORAL	12.5MG;20MG	0	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
002	TABLET;ORAL	25MG;40MG	0	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
003	TABLET;ORAL	12.5MG;40MG	0	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-09-17	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-01-25	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

UMEDICA LABS PVT LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208847
            [companyName] => UMEDICA LABS PVT LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL","strength":"12.5MG;20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL","strength":"25MG;40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL","strength":"12.5MG;40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/17\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-09-17
        )

)