ANDA 211858

SUN PHARM

FDA Drug Application

Application #211858

Application Sponsors

ANDA 211858

SUN PHARM

Marketing Status

• Prescription: 001

Application Products

001

TABLET, DELAYED RELEASE;ORAL

1.2GM

0

MESALAMINE

MESALAMINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-01-25	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-03-22	STANDARD
LABELING; Labeling	SUPPL	5	AP	2021-03-22	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-03-22	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	5	Null	15
SUPPL	6	Null	15

TE Codes

001

Prescription

AB

CDER Filings

SUN PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211858
            [companyName] => SUN PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"MESALAMINE","activeIngredients":"MESALAMINE","strength":"1.2GM","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/25\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/19\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-05-19
        )

)