ANDA 200462

MYLAN PHARMS INC

FDA Drug Application

Application #200462

Application Sponsors

ANDA 200462

MYLAN PHARMS INC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004
• Discontinued: 005
• Discontinued: 006

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	EQ 2MG BASE	0	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	EQ 3MG BASE	0	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE
003	TABLET, EXTENDED RELEASE;ORAL	EQ 4MG BASE	0	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE
004	TABLET, EXTENDED RELEASE;ORAL	EQ 6MG BASE	0	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE
005	TABLET, EXTENDED RELEASE;ORAL	EQ 8MG BASE	0	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE
006	TABLET, EXTENDED RELEASE;ORAL	EQ 12MG BASE	0	ROPINIROLE HYDROCHLORIDE	ROPINIROLE HYDROCHLORIDE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2012-10-15
LABELING; Labeling	SUPPL	4	AP	2015-10-16	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	15

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200462
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ROPINIROLE HYDROCHLORIDE","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 2MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ROPINIROLE HYDROCHLORIDE","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 3MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ROPINIROLE HYDROCHLORIDE","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 4MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ROPINIROLE HYDROCHLORIDE","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 6MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ROPINIROLE HYDROCHLORIDE","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 8MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ROPINIROLE HYDROCHLORIDE","activeIngredients":"ROPINIROLE HYDROCHLORIDE","strength":"EQ 12MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/15\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/16\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-10-16
        )

)