ANDA 090841

ETHYPHARM

FDA Drug Application

Application #090841

Application Sponsors

ANDA 090841

ETHYPHARM

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

ORIG

1

AP

2021-03-31

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ETHYPHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90841
            [companyName] => ETHYPHARM
            [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":"ESOMEPRAZOLE MAGNESIUM","submission":"ESOMEPRAZOLE MAGNESIUM","actionType":"EQ 20MG BASE","submissionClassification":"CAPSULE, DELAYED REL PELLETS;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ESOMEPRAZOLE MAGNESIUM","submission":"ESOMEPRAZOLE MAGNESIUM","actionType":"EQ 40MG BASE","submissionClassification":"CAPSULE, DELAYED REL PELLETS;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)