ANDA 203817

ACTAVIS LABS FL

FDA Drug Application

Application #203817

Documents

• Letter: 2017-11-08

Application Sponsors

ANDA 203817

ACTAVIS LABS FL

Marketing Status

• Prescription: 001

Application Products

001

TABLET, DELAYED RELEASE;ORAL

1.2GM

0

MESALAMINE

MESALAMINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-03-23
LABELING; Labeling	SUPPL	3	AP	2020-05-29	STANDARD
LABELING; Labeling	SUPPL	8	AP	2021-12-06	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	3	Null	15
SUPPL	8	Null	15

TE Codes

001

Prescription

AB

CDER Filings

ACTAVIS LABS FL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203817
            [companyName] => ACTAVIS LABS FL
            [docInserts] => ["",""]
            [products] => [{"drugName":"MESALAMINE","activeIngredients":"MESALAMINE","strength":"1.2GM","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/23\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/203817Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/29\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-05-29
        )

)