ANDA 205563

LANNETT CO INC

FDA Drug Application

Application #205563

Application Sponsors

ANDA 205563

LANNETT CO INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE, DELAYED REL PELLETS;ORAL	EQ 20MG BASE	0	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM
002	CAPSULE, DELAYED REL PELLETS;ORAL	EQ 40MG BASE	0	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-09-01

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

LANNETT CO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205563
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESOMEPRAZOLE MAGNESIUM","activeIngredients":"ESOMEPRAZOLE MAGNESIUM","strength":"EQ 20MG BASE","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESOMEPRAZOLE MAGNESIUM","activeIngredients":"ESOMEPRAZOLE MAGNESIUM","strength":"EQ 40MG BASE","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/01\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-09-01
        )

)