ANDA 091610

ACTAVIS LABS FL INC

FDA Drug Application

Application #091610

Application Sponsors

ANDA 091610

ACTAVIS LABS FL INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

8MG

0

RAMELTEON

RAMELTEON

FDA Submissions

	ORIG	1	AP	2015-08-19
LABELING; Labeling	SUPPL	2	AP	2020-02-07	STANDARD

Submissions Property Types

ORIG	1	Null	17
SUPPL	2	Null	15

TE Codes

001

Prescription

AB

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91610
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"RAMELTEON","activeIngredients":"RAMELTEON","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RAMELTEON","submission":"RAMELTEON","actionType":"8MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)