ENALTEC FDA Approval ANDA 215435

ANDA 215435

ENALTEC

FDA Drug Application

Application #215435

Application Sponsors

ANDA 215435ENALTEC

Marketing Status

Prescription001

Application Products

001TABLET;ORAL8MG0RAMELTEONRAMELTEON

FDA Submissions

UNKNOWN; ORIG1AP2022-08-24STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

ENALTEC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215435
            [companyName] => ENALTEC
            [docInserts] => ["",""]
            [products] => [{"drugName":"RAMELTEON","activeIngredients":"RAMELTEON","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/24\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-24
        )

)

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