ANDA 213820

RISING

FDA Drug Application

Application #213820

Documents

• Letter: 2021-01-12

Application Sponsors

ANDA 213820

RISING

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

500MG

0

NITAZOXANIDE

NITAZOXANIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-11-27	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-08-11	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001

Prescription

AB

CDER Filings

RISING

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213820
            [companyName] => RISING
            [docInserts] => ["",""]
            [products] => [{"drugName":"NITAZOXANIDE","activeIngredients":"NITAZOXANIDE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/27\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-27
        )

)