ANDA 212949

CSPC OUYI

FDA Drug Application

Application #212949

Application Sponsors

ANDA 212949

CSPC OUYI

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

2020-10-02

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

CSPC OUYI

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212949
            [companyName] => CSPC OUYI
            [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":"10\/02\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-02
        )

)