ANDA 090654

SUN PHARM INDS

FDA Drug Application

Application #090654

Application Sponsors

ANDA 090654

SUN PHARM INDS

Marketing Status

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

Application Products

001	TABLET;ORAL	25MG;50MG	0	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE
002	TABLET;ORAL	25MG;100MG	0	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE
003	TABLET;ORAL	50MG;100MG	0	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE

FDA Submissions

ORIG

1

AP

2012-01-19

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

SUN PHARM INDS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90654
            [companyName] => SUN PHARM INDS
            [docInserts] => ["",""]
            [products] => [{"drugName":"METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE","strength":"25MG;50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE","strength":"25MG;100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE","strength":"50MG;100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE","actionType":"25MG;50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE","actionType":"25MG;100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE","actionType":"50MG;100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)