Application Sponsors
ANDA 076715 | WATSON LABS INC | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET;ORAL | 100MG | 0 | MODAFINIL | MODAFINIL |
002 | TABLET;ORAL | 200MG | 0 | MODAFINIL | MODAFINIL |
FDA Submissions
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
WATSON LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 76715
[companyName] => WATSON LABS INC
[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":"MODAFINIL","submission":"MODAFINIL","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MODAFINIL","submission":"MODAFINIL","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)