ANDA 209966

CADILA

FDA Drug Application

Application #209966

Application Sponsors

ANDA 209966

CADILA

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

2017-09-14

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

CADILA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209966
            [companyName] => CADILA
            [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":"09\/14\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-09-14
        )

)