ANDA 203349

GLAND PHARMA LTD

FDA Drug Application

Application #203349

Application Sponsors

ANDA 203349

GLAND PHARMA LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INTRAVENOUS	EQ 20MG BASE/VIAL	0	ESOMEPRAZOLE SODIUM	ESOMEPRAZOLE SODIUM
002	INJECTABLE;INTRAVENOUS	EQ 40MG BASE/VIAL	0	ESOMEPRAZOLE SODIUM	ESOMEPRAZOLE SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-04-01

Submissions Property Types

ORIG

1

Null

19

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203349
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESOMEPRAZOLE SODIUM","activeIngredients":"ESOMEPRAZOLE SODIUM","strength":"EQ 20MG BASE\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESOMEPRAZOLE SODIUM","activeIngredients":"ESOMEPRAZOLE SODIUM","strength":"EQ 40MG BASE\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/01\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-04-01
        )

)