ANDA 215266

PADAGIS ISRAEL

FDA Drug Application

Application #215266

Documents

• Letter: 2022-12-20

Application Sponsors

ANDA 215266

PADAGIS ISRAEL

Marketing Status

• None (Tentative Approval): 001

Application Products

001

FOAM;TOPICAL

0.05%

0

HALOBETASOL PROPIONATE

HALOBETASOL PROPIONATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-10-17

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

PADAGIS ISRAEL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215266
            [companyName] => PADAGIS ISRAEL
            [docInserts] => ["",""]
            [products] => [{"drugName":"HALOBETASOL PROPIONATE","activeIngredients":"HALOBETASOL PROPIONATE","strength":"0.05%","dosageForm":"FOAM;TOPICAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/17\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-17
        )

)