ANDA 216209

XIROMED

FDA Drug Application

Application #216209

Application Sponsors

ANDA 216209

XIROMED

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

8MG

0

RAMELTEON

RAMELTEON

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-11-25

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

XIROMED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216209
            [companyName] => XIROMED
            [docInserts] => ["",""]
            [products] => [{"drugName":"RAMELTEON","activeIngredients":"RAMELTEON","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/25\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-11-25
        )

)