Documents
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
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
)
)