ANDA 205181

TARO PHARMS

FDA Drug Application

Application #205181

Documents

• Letter: 2017-12-18
• Review: 2020-07-22

Application Sponsors

ANDA 205181

TARO PHARMS

Marketing Status

• Over-the-counter: 001

Application Products

001

CREAM;TOPICAL

1%

0

BUTENAFINE HYDROCHLORIDE

BUTENAFINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-11-16

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

TARO PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205181
            [companyName] => TARO PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUTENAFINE HYDROCHLORIDE","activeIngredients":"BUTENAFINE HYDROCHLORIDE","strength":"1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/16\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/205181Orig1s000ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/205181Orig1_Approval_Pkg.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-11-16
        )

)