ANDA 210720

TARO

FDA Drug Application

Application #210720

Documents

• Letter: 2018-07-06

Application Sponsors

ANDA 210720

TARO

Marketing Status

• Prescription: 001

Application Products

001

LOTION;TOPICAL

0.5%

0

IVERMECTIN

IVERMECTIN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-05-06	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-01-06	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7

TE Codes

001

Prescription

AB

CDER Filings

TARO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210720
            [companyName] => TARO
            [docInserts] => ["",""]
            [products] => [{"drugName":"IVERMECTIN","activeIngredients":"IVERMECTIN","strength":"0.5%","dosageForm":"LOTION;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/06\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/210720Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/06\/2021","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2021-01-06
        )

)