ANDA 208107

WATSON LABS INC

FDA Drug Application

Application #208107

Application Sponsors

ANDA 208107

WATSON LABS INC

Marketing Status

• Prescription: 001

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

ORIG	1	Null	15
SUPPL	2	Null	31

TE Codes

001

Prescription

AB

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
        )

)