ANDA 078995

MYLAN PHARMS INC

FDA Drug Application

Application #078995

Documents

• Review: 2012-05-09
• Review: 2012-04-13

Application Sponsors

ANDA 078995

MYLAN PHARMS INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

EQ 150MG BASE

0

IBANDRONATE SODIUM

IBANDRONATE SODIUM

FDA Submissions

	ORIG	1	AP	2012-03-19
LABELING; Labeling	SUPPL	3	AP	2015-08-13	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78995
            [companyName] => MYLAN PHARMS INC
            [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
        )

)