ANDA 208201

TARO

FDA Drug Application

Application #208201

Documents

• Letter: 2019-05-22

Application Sponsors

ANDA 208201

TARO

Marketing Status

• Discontinued: 001

Application Products

001

GEL;TOPICAL

2%

0

NAFTIFINE HYDROCHLORIDE

NAFTIFINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-04-10	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-11-12	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7

CDER Filings

TARO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208201
            [companyName] => TARO
            [docInserts] => ["",""]
            [products] => [{"drugName":"NAFTIFINE HYDROCHLORIDE","activeIngredients":"NAFTIFINE HYDROCHLORIDE","strength":"2%","dosageForm":"GEL;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/10\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/208201Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/12\/2021","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/28\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2021-11-12
        )

)