ANDA 211751

CIPLA

FDA Drug Application

Application #211751

Documents

• Letter: 2020-05-19

Application Sponsors

ANDA 211751

CIPLA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	FOR SUSPENSION, DELAYED RELEASE;ORAL	EQ 20MG BASE/PACKET	0	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM
002	FOR SUSPENSION, DELAYED RELEASE;ORAL	EQ 40MG BASE/PACKET	0	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-03-23

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

CIPLA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211751
            [companyName] => CIPLA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESOMEPRAZOLE MAGNESIUM","activeIngredients":"ESOMEPRAZOLE MAGNESIUM","strength":"EQ 20MG BASE\/PACKET","dosageForm":"FOR SUSPENSION, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESOMEPRAZOLE MAGNESIUM","activeIngredients":"ESOMEPRAZOLE MAGNESIUM","strength":"EQ 40MG BASE\/PACKET","dosageForm":"FOR SUSPENSION, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/23\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/211751Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-03-23
        )

)