ANDA 205975

TARO PHARMS

FDA Drug Application

Application #205975

Application Sponsors

ANDA 205975

TARO PHARMS

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

1%

0

NAFTIFINE HYDROCHLORIDE

NAFTIFINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-09-08

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

TARO PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205975
            [companyName] => TARO PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"NAFTIFINE HYDROCHLORIDE","activeIngredients":"NAFTIFINE HYDROCHLORIDE","strength":"1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/08\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/03\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-12-03
        )

)