ANDA 200156

WATSON LABS INC

FDA Drug Application

Application #200156

Documents

• Letter: 2013-06-04

Application Sponsors

ANDA 200156

WATSON LABS INC

Marketing Status

• None (Tentative Approval): 001
• Discontinued: 002
• None (Tentative Approval): 003
• Discontinued: 004
• None (Tentative Approval): 005

Application Products

001	TABLET; ORAL	50MG	0	ARMODAFINIL	ARMODAFINIL
002	TABLET;ORAL	100MG	0	ARMODAFINIL	ARMODAFINIL
003	TABLET; ORAL	150MG	0	ARMODAFINIL	ARMODAFINIL
004	TABLET;ORAL	200MG	0	ARMODAFINIL	ARMODAFINIL
005	TABLET; ORAL	2500MG	0	ARMODAFINIL	ARMODAFINIL

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2012-08-29
N/A; Not Applicable	ORIG	2	TA	2012-08-29

Submissions Property Types

ORIG

1

Null

7

CDER Filings

WATSON LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200156
            [companyName] => WATSON LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARMODAFINIL","activeIngredients":"ARMODAFINIL","strength":"50MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ARMODAFINIL","activeIngredients":"ARMODAFINIL","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ARMODAFINIL","activeIngredients":"ARMODAFINIL","strength":"150MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ARMODAFINIL","activeIngredients":"ARMODAFINIL","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ARMODAFINIL","activeIngredients":"ARMODAFINIL","strength":"2500MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/29\/2012","submission":"ORIG-2","actionType":"Tentative Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/29\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/200156Orig1s000.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/25\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-01-25
        )

)