ANDA 079142

MYLAN PHARMS INC

FDA Drug Application

Application #079142

Documents

• Letter: 2012-08-06

Application Sponsors

ANDA 079142

MYLAN PHARMS INC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET, CHEWABLE;ORAL	EQ 4MG BASE	0	MONTELUKAST SODIUM	MONTELUKAST SODIUM
002	TABLET, CHEWABLE;ORAL	EQ 5MG BASE	0	MONTELUKAST SODIUM	MONTELUKAST SODIUM

FDA Submissions

	ORIG	1	AP	2012-08-03
LABELING; Labeling	SUPPL	2	AP	2012-12-12	STANDARD
LABELING; Labeling	SUPPL	4	AP	2015-03-16	STANDARD
LABELING; Labeling	SUPPL	5	AP	2015-03-16	STANDARD
LABELING; Labeling	SUPPL	8	AP	2015-03-16	STANDARD
LABELING; Labeling	SUPPL	9	AP	2015-10-08	STANDARD
LABELING; Labeling	SUPPL	14	AP	2019-10-22	STANDARD
LABELING; Labeling	SUPPL	15	AP	2019-10-22	STANDARD
LABELING; Labeling	SUPPL	16	AP	2020-08-18	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	4	Null	7
SUPPL	5	Null	7
SUPPL	8	Null	7
SUPPL	9	Null	7
SUPPL	14	Null	7
SUPPL	15	Null	7
SUPPL	16	Null	15

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79142
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MONTELUKAST SODIUM","activeIngredients":"MONTELUKAST SODIUM","strength":"EQ 4MG BASE","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MONTELUKAST SODIUM","activeIngredients":"MONTELUKAST SODIUM","strength":"EQ 5MG BASE","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MONTELUKAST SODIUM","submission":"MONTELUKAST SODIUM","actionType":"EQ 4MG BASE","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MONTELUKAST SODIUM","submission":"MONTELUKAST SODIUM","actionType":"EQ 5MG BASE","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)