ANDA 206370

TARO

FDA Drug Application

Application #206370

Documents

• Letter: 2020-05-14

Application Sponsors

ANDA 206370

TARO

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

0.1%

0

CLOCORTOLONE PIVALATE

CLOCORTOLONE PIVALATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-04-21

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

TARO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206370
            [companyName] => TARO
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLOCORTOLONE PIVALATE","activeIngredients":"CLOCORTOLONE PIVALATE","strength":"0.1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/21\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/206370Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-04-21
        )

)