ANDA 213815

APPCO

FDA Drug Application

Application #213815

Application Sponsors

ANDA 213815

APPCO

Marketing Status

• Prescription: 001

Application Products

001

UNKNOWN

UNKNOWN

0

RAMELTEON

RAMELTEON

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-10-26

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

APPCO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213815
            [companyName] => APPCO
            [docInserts] => ["",""]
            [products] => [{"drugName":"RAMELTEON","activeIngredients":"RAMELTEON","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/26\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-26
        )

)