ANDA 074644

SUN PHARM INDS INC

FDA Drug Application

Application #074644

Application Sponsors

ANDA 074644

SUN PHARM INDS INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	50MG	0	METOPROLOL TARTRATE	METOPROLOL TARTRATE
002	TABLET;ORAL	100MG	0	METOPROLOL TARTRATE	METOPROLOL TARTRATE

FDA Submissions

	ORIG	1	AP	1996-12-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2002-10-11
LABELING; Labeling	SUPPL	10	AP	2003-03-10
LABELING; Labeling	SUPPL	19	AP	2011-03-03
LABELING; Labeling	SUPPL	20	AP	2006-11-17
LABELING; Labeling	SUPPL	22	AP	2008-09-16
LABELING; Labeling	SUPPL	24	AP	2009-06-15
LABELING; Labeling	SUPPL	25	AP	2008-03-05
LABELING; Labeling	SUPPL	28	AP	2008-12-15
LABELING; Labeling	SUPPL	29	AP	2010-02-26
LABELING; Labeling	SUPPL	31	AP	2013-02-19
LABELING; Labeling	SUPPL	37	AP	2015-10-26	STANDARD
LABELING; Labeling	SUPPL	40	AP	2015-10-26	STANDARD

Submissions Property Types

SUPPL	4	Null	0
SUPPL	19	Null	7
SUPPL	29	Null	7
SUPPL	31	Null	7
SUPPL	37	Null	8
SUPPL	40	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

SUN PHARM INDS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74644
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METOPROLOL TARTRATE","activeIngredients":"METOPROLOL TARTRATE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METOPROLOL TARTRATE","activeIngredients":"METOPROLOL TARTRATE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METOPROLOL TARTRATE","submission":"METOPROLOL TARTRATE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METOPROLOL TARTRATE","submission":"METOPROLOL TARTRATE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)