ANDA 078996

SUN PHARM INDUSTRIES

FDA Drug Application

Application #078996

Application Sponsors

ANDA 078996

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

EQ 150MG BASE

0

IBANDRONATE SODIUM

IBANDRONATE SODIUM

FDA Submissions

	ORIG	1	AP	2012-08-15
LABELING; Labeling	SUPPL	3	AP	2015-07-22	STANDARD
LABELING; Labeling	SUPPL	4	AP	2015-07-22	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7
SUPPL	4	Null	15

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78996
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBANDRONATE SODIUM","activeIngredients":"IBANDRONATE SODIUM","strength":"EQ 150MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IBANDRONATE SODIUM","submission":"IBANDRONATE SODIUM","actionType":"EQ 150MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)