EDENBRIDGE PHARMS FDA Approval ANDA 213796

ANDA 213796

EDENBRIDGE PHARMS

FDA Drug Application

Application #213796

Application Sponsors

ANDA 213796EDENBRIDGE PHARMS

Marketing Status

Prescription001

Application Products

001CAPSULE;ORALEQ 150MG BASE0DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-04-19STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

EDENBRIDGE PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213796
            [companyName] => EDENBRIDGE PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXEPIN HYDROCHLORIDE","activeIngredients":"DOXEPIN HYDROCHLORIDE","strength":"EQ 150MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/19\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-04-19
        )

)

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