ANDA 211618

LEADING PHARMA LLC

FDA Drug Application

Application #211618

Application Sponsors

ANDA 211618

LEADING PHARMA LLC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

EQ 150MG BASE

0

DOXEPIN HYDROCHLORIDE

DOXEPIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-03-01

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

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
        )

)