ANDA 210559

INDCHEMIE HEALTH

FDA Drug Application

Application #210559

Application Sponsors

ANDA 210559

INDCHEMIE HEALTH

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

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

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-02-26

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

INDCHEMIE HEALTH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210559
            [companyName] => INDCHEMIE HEALTH
            [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":"02\/26\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-26
        )

)