Application Sponsors
ANDA 208107 | WATSON LABS INC | |
Marketing Status
Application Products
001 | CAPSULE;ORAL | 100MG | 0 | AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2016-12-06 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2017-06-22 | UNKNOWN |
Submissions Property Types
TE Codes
CDER Filings
WATSON LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 208107
[companyName] => WATSON LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"AMANTADINE HYDROCHLORIDE","activeIngredients":"AMANTADINE HYDROCHLORIDE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/06\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"06\/22\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2017-06-22
)
)