ANDA 076670

SUN PHARM INDS INC

FDA Drug Application

Application #076670

Application Sponsors

ANDA 076670

SUN PHARM INDS INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

25MG

0

METOPROLOL TARTRATE

METOPROLOL TARTRATE

FDA Submissions

	ORIG	1	AP	2004-01-15
LABELING; Labeling	SUPPL	3	AP	2009-06-15
LABELING; Labeling	SUPPL	4	AP	2008-03-05
LABELING; Labeling	SUPPL	7	AP	2008-12-15
LABELING; Labeling	SUPPL	8	AP	2010-02-26
LABELING; Labeling	SUPPL	11	AP	2013-02-19
LABELING; Labeling	SUPPL	16	AP	2015-10-26	STANDARD
LABELING; Labeling	SUPPL	18	AP	2015-10-26	STANDARD

Submissions Property Types

SUPPL	8	Null	7
SUPPL	11	Null	15
SUPPL	16	Null	15
SUPPL	18	Null	15

TE Codes

001

Prescription

AB

CDER Filings

SUN PHARM INDS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76670
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METOPROLOL TARTRATE","activeIngredients":"METOPROLOL TARTRATE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METOPROLOL TARTRATE","submission":"METOPROLOL TARTRATE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)