ANDA 213186

GRANULES PHARMS

FDA Drug Application

Application #213186

Application Sponsors

ANDA 213186

GRANULES PHARMS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

8MG

0

RAMELTEON

RAMELTEON

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-08-21	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-08-04	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-03-28	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	4	Null	15

TE Codes

001

Prescription

AB

CDER Filings

GRANULES PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213186
            [companyName] => GRANULES PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"RAMELTEON","activeIngredients":"RAMELTEON","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/21\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-21
        )

)