ANDA 208209

ACCORD HLTHCARE INC

FDA Drug Application

Application #208209

Application Sponsors

ANDA 208209

ACCORD HLTHCARE INC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003

Application Products

001	TABLET;ORAL	10MG	0	VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE
002	TABLET;ORAL	20MG	0	VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE
003	TABLET;ORAL	40MG	0	VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2017-07-11

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ACCORD HLTHCARE INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208209
            [companyName] => ACCORD HLTHCARE INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"VILAZODONE HYDROCHLORIDE","activeIngredients":"VILAZODONE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"VILAZODONE HYDROCHLORIDE","activeIngredients":"VILAZODONE HYDROCHLORIDE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"VILAZODONE HYDROCHLORIDE","activeIngredients":"VILAZODONE HYDROCHLORIDE","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/11\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-07-11
        )

)