ANDA 078975

AKORN

FDA Drug Application

Application #078975

Application Sponsors

ANDA 078975

AKORN

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;TOPICAL

8%

0

CICLOPIROX

CICLOPIROX

FDA Submissions

ORIG

1

AP

2010-02-17

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AT

CDER Filings

AKORN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78975
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"CICLOPIROX","activeIngredients":"CICLOPIROX","strength":"8%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CICLOPIROX","submission":"CICLOPIROX","actionType":"8%","submissionClassification":"SOLUTION;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)