ANDA 204801

MACLEODS PHARMS LTD

FDA Drug Application

Application #204801

Application Sponsors

ANDA 204801

MACLEODS PHARMS LTD

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003

Application Products

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

FDA Submissions

ORIG

1

TA

2015-12-02

Submissions Property Types

ORIG

1

Null

0

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204801
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL","strength":"20MG;12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL","strength":"40MG;12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL","strength":"40MG;25MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/02\/2015","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-12-02
        )

)