ANDA 206901

TARO PHARMS

FDA Drug Application

Application #206901

Documents

• Letter: 2016-01-08

Application Sponsors

ANDA 206901

TARO PHARMS

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

2%

0

NAFTIFINE HYDROCHLORIDE

NAFTIFINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-01-06	STANDARD
LABELING; Labeling	SUPPL	2	AP	2019-12-03	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7

TE Codes

001

Prescription

AB

CDER Filings

TARO PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206901
            [companyName] => TARO PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"NAFTIFINE HYDROCHLORIDE","activeIngredients":"NAFTIFINE HYDROCHLORIDE","strength":"2%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/06\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/206901Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/03\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/03\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-12-03
        )

)