ANDA 091550

PERRIGO ISRAEL

FDA Drug Application

Application #091550

Application Sponsors

ANDA 091550

PERRIGO ISRAEL

Marketing Status

• Prescription: 001

Application Products

001

AEROSOL, FOAM;TOPICAL

2%

0

KETOCONAZOLE

KETOCONAZOLE

FDA Submissions

ORIG

1

AP

2011-08-25

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AT

CDER Filings

PERRIGO ISRAEL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91550
            [companyName] => PERRIGO ISRAEL
            [docInserts] => ["",""]
            [products] => [{"drugName":"KETOCONAZOLE","activeIngredients":"KETOCONAZOLE","strength":"2%","dosageForm":"AEROSOL, FOAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"KETOCONAZOLE","submission":"KETOCONAZOLE","actionType":"2%","submissionClassification":"AEROSOL, FOAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)