ANDA 213725

SUN PHARM

FDA Drug Application

Application #213725

Documents

• Letter: 2020-08-24

Application Sponsors

ANDA 213725

SUN PHARM

Marketing Status

• Prescription: 001

Application Products

001

FOR SUSPENSION, DELAYED RELEASE;ORAL

EQ 40MG BASE

0

PANTOPRAZOLE SODIUM

PANTOPRAZOLE SODIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-06-30	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-09-27	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	7

TE Codes

001

Prescription

AB

CDER Filings

SUN PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213725
            [companyName] => SUN PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"PANTOPRAZOLE SODIUM","activeIngredients":"PANTOPRAZOLE SODIUM","strength":"EQ 40MG BASE","dosageForm":"FOR SUSPENSION, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/30\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-30
        )

)