ANDA 040547

ECI PHARMS LLC

FDA Drug Application

Application #040547

Application Sponsors

ANDA 040547

ECI PHARMS LLC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Discontinued: 004

Application Products

001	TABLET;ORAL	5MG	0	METHIMAZOLE	METHIMAZOLE
002	TABLET;ORAL	10MG	0	METHIMAZOLE	METHIMAZOLE
003	TABLET; ORAL	20MG	0	METHIMAZOLE	METHIMAZOLE
004	TABLET;ORAL	20MG	0	METHIMAZOLE	METHIMAZOLE

FDA Submissions

	ORIG	1	AP	2005-02-18
LABELING; Labeling	SUPPL	9	AP	2016-01-15	STANDARD
LABELING; Labeling	SUPPL	11	AP	2019-01-18	STANDARD

Submissions Property Types

SUPPL	9	Null	7
SUPPL	11	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

DISCOVERY THERAP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40547
            [companyName] => DISCOVERY THERAP
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHIMAZOLE","activeIngredients":"METHIMAZOLE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHIMAZOLE","activeIngredients":"METHIMAZOLE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHIMAZOLE","activeIngredients":"METHIMAZOLE","strength":"20MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"METHIMAZOLE","activeIngredients":"METHIMAZOLE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHIMAZOLE","submission":"METHIMAZOLE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METHIMAZOLE","submission":"METHIMAZOLE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METHIMAZOLE","submission":"METHIMAZOLE","actionType":"20MG","submissionClassification":"TABLET; ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METHIMAZOLE","submission":"METHIMAZOLE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)