ANDA 202068

RISING

FDA Drug Application

Application #202068

Application Sponsors

ANDA 202068

RISING

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	5MG	0	METHIMAZOLE	METHIMAZOLE
002	TABLET;ORAL	10MG	0	METHIMAZOLE	METHIMAZOLE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2012-03-07
LABELING; Labeling	SUPPL	3	AP	2016-01-15	STANDARD
LABELING; Labeling	SUPPL	4	AP	2019-01-23	STANDARD
LABELING; Labeling	SUPPL	5	AP	2021-10-20	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	7
SUPPL	4	Null	7
SUPPL	5	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

RISING

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202068
            [companyName] => RISING
            [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"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/07\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/23\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/15\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-01-23
        )

)