ANDA 077123

PERRIGO ISRAEL

FDA Drug Application

Application #077123

Documents

• Letter: 2004-12-23

Application Sponsors

ANDA 077123

PERRIGO ISRAEL

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

0.05%

0

HALOBETASOL PROPIONATE

HALOBETASOL PROPIONATE

FDA Submissions

ORIG

1

AP

2004-12-16

TE Codes

001

Prescription

AB

CDER Filings

PERRIGO ISRAEL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77123
            [companyName] => PERRIGO ISRAEL
            [docInserts] => ["",""]
            [products] => [{"drugName":"HALOBETASOL PROPIONATE","activeIngredients":"HALOBETASOL PROPIONATE","strength":"0.05%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HALOBETASOL PROPIONATE","submission":"HALOBETASOL PROPIONATE","actionType":"0.05%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)