ANDA 078046

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #078046

Documents

• Letter: 2007-09-25

Application Sponsors

ANDA 078046

ACTAVIS MID ATLANTIC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;TOPICAL

8%

0

CICLOPIROX

CICLOPIROX

FDA Submissions

ORIG

1

AP

2007-09-18

TE Codes

001

Prescription

AT

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78046
            [companyName] => ACTAVIS MID ATLANTIC
            [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
        )

)