ANDA 200043

MYLAN PHARMS INC

FDA Drug Application

Application #200043

Documents

• Letter: 2012-06-07

Application Sponsors

ANDA 200043

MYLAN PHARMS INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005

Application Products

001	TABLET;ORAL	50MG	0	ARMODAFINIL	ARMODAFINIL
002	TABLET;ORAL	150MG	0	ARMODAFINIL	ARMODAFINIL
003	TABLET;ORAL	250MG	0	ARMODAFINIL	ARMODAFINIL
004	TABLET;ORAL	100MG	0	ARMODAFINIL	ARMODAFINIL
005	TABLET;ORAL	200MG	0	ARMODAFINIL	ARMODAFINIL

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2012-06-01
N/A; Not Applicable	ORIG	2	AP	2019-05-09
LABELING; Labeling	SUPPL	4	AP	2016-01-20	STANDARD
LABELING; Labeling	SUPPL	6	AP	2019-12-13	STANDARD

Submissions Property Types

ORIG	1	Null	15
ORIG	2	Null	7
SUPPL	4	Null	15
SUPPL	6	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200043
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARMODAFINIL","activeIngredients":"ARMODAFINIL","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ARMODAFINIL","activeIngredients":"ARMODAFINIL","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ARMODAFINIL","activeIngredients":"ARMODAFINIL","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ARMODAFINIL","activeIngredients":"ARMODAFINIL","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ARMODAFINIL","activeIngredients":"ARMODAFINIL","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/09\/2019","submission":"ORIG-2","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/01\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/200043s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/13\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/20\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/20\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-12-13
        )

)