LEADING PHARMA LLC FDA Approval ANDA 211618

ANDA 211618

LEADING PHARMA LLC

FDA Drug Application

Application #211618

Application Sponsors

ANDA 211618LEADING PHARMA LLC

Marketing Status

Prescription001

Application Products

001CAPSULE;ORALEQ 150MG BASE0DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-03-01STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

LEADING PHARMA LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211618
            [companyName] => LEADING PHARMA LLC
            [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":"03\/01\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-01
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.