NDA 020529

ALLERGAN

FDA Drug Application

Application #020529

Documents

• Label: 2018-12-12

Application Sponsors

NDA 020529

ALLERGAN

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

0.5%

1

CONDYLOX

PODOFILOX

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

1997-03-13

STANDARD

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20529
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"CONDYLOX","activeIngredients":"PODOFILOX","strength":"0.5%","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/13\/1997","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1997\\\/020529s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CONDYLOX","submission":"PODOFILOX","actionType":"0.5%","submissionClassification":"GEL;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1997-03-13
        )

)