ANDA 211464

PERRIGO ISRAEL

FDA Drug Application

Application #211464

Documents

• Letter: 2018-12-20
• Letter: 2020-08-26

Application Sponsors

ANDA 211464

PERRIGO ISRAEL

Marketing Status

• None (Tentative Approval): 001

Application Products

001

LOTION;TOPICAL

0.05%

0

HALOBETASOL PROPIONATE

HALOBETASOL PROPIONATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-11-20

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

PERRIGO ISRAEL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211464
            [companyName] => PERRIGO ISRAEL
            [docInserts] => ["",""]
            [products] => [{"drugName":"HALOBETASOL PROPIONATE","activeIngredients":"HALOBETASOL PROPIONATE","strength":"0.05%","dosageForm":"LOTION;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/03\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/211464Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-03
        )

)