ANDA 210509

AMNEAL PHARMS LLC

FDA Drug Application

Application #210509

Application Sponsors

ANDA 210509

AMNEAL PHARMS LLC

Marketing Status

• Prescription: 001

Application Products

001

SUPPOSITORY;RECTAL

1GM

0

MESALAMINE

MESALAMINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-01-02	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-10-28	STANDARD
LABELING; Labeling	SUPPL	6	AP	2022-10-28	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	2	Null	7
SUPPL	6	Null	7

TE Codes

001

Prescription

AB

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210509
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"MESALAMINE","activeIngredients":"MESALAMINE","strength":"1GM","dosageForm":"SUPPOSITORY;RECTAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/02\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-01-02
        )

)