ANDA 207196

APPCO

FDA Drug Application

Application #207196

Application Sponsors

ANDA 207196

APPCO

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	100MG	0	MODAFINIL	MODAFINIL
002	TABLET;ORAL	200MG	0	MODAFINIL	MODAFINIL

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-08-16	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-01-28	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

APPCO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207196
            [companyName] => APPCO
            [docInserts] => ["",""]
            [products] => [{"drugName":"MODAFINIL","activeIngredients":"MODAFINIL","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MODAFINIL","activeIngredients":"MODAFINIL","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/16\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/28\/2021","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2021-01-28
        )

)