ANDA 202431

MYLAN PHARMS INC

FDA Drug Application

Application #202431

Application Sponsors

ANDA 202431

MYLAN PHARMS INC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	EQ 1MG BASE	0	NARATRIPTAN	NARATRIPTAN HYDROCHLORIDE
002	TABLET;ORAL	EQ 2.5MG BASE	0	NARATRIPTAN	NARATRIPTAN HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2012-05-31
LABELING; Labeling	SUPPL	3	AP	2020-10-20	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202431
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NARATRIPTAN","activeIngredients":"NARATRIPTAN HYDROCHLORIDE","strength":"EQ 1MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NARATRIPTAN","activeIngredients":"NARATRIPTAN HYDROCHLORIDE","strength":"EQ 2.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/31\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/16\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-09-16
        )

)