ANDA 204380

ACTAVIS LLC

FDA Drug Application

Application #204380

Application Sponsors

ANDA 204380

ACTAVIS LLC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	25MG	0	DAPSONE	DAPSONE
002	TABLET;ORAL	100MG	0	DAPSONE	DAPSONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-03-23

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ACTAVIS LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204380
            [companyName] => ACTAVIS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DAPSONE","activeIngredients":"DAPSONE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DAPSONE","activeIngredients":"DAPSONE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/23\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-03-23
        )

)