ANDA 202768

NATCO PHARMA LTD

FDA Drug Application

Application #202768

Documents

• Letter: 2014-10-21

Application Sponsors

ANDA 202768

NATCO PHARMA LTD

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

UNKNOWN;	ORIG	1	AP	2016-11-28
LABELING; Labeling	SUPPL	2	AP	2017-08-08	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

TE Codes

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

CDER Filings

NATCO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202768
            [companyName] => NATCO PHARMA LTD
            [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":"11\/28\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202768Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/08\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-08-08
        )

)