ANDA 040619

ECI PHARMS LLC

FDA Drug Application

Application #040619

Application Sponsors

ANDA 040619

ECI PHARMS LLC

Marketing Status

• Discontinued: 003

Application Products

003

TABLET;ORAL

15MG

0

METHIMAZOLE

METHIMAZOLE

FDA Submissions

	ORIG	1	AP	2005-07-12
LABELING; Labeling	SUPPL	3	AP	2016-01-15	STANDARD
LABELING; Labeling	SUPPL	4	AP	2019-01-18	STANDARD

Submissions Property Types

SUPPL	3	Null	15
SUPPL	4	Null	15

CDER Filings

DISCOVERY THERAP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40619
            [companyName] => DISCOVERY THERAP
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHIMAZOLE","activeIngredients":"METHIMAZOLE","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHIMAZOLE","submission":"METHIMAZOLE","actionType":"15MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)