ANDA 200923

PERRIGO ISRAEL

FDA Drug Application

Application #200923

Application Sponsors

ANDA 200923

PERRIGO ISRAEL

Marketing Status

• Prescription: 001

Application Products

001

CREAM;VAGINAL

2%

0

GYNAZOLE-1

BUTOCONAZOLE NITRATE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2012-05-18
LABELING; Labeling	SUPPL	4	AP	2015-06-17	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	15

CDER Filings

PERRIGO ISRAEL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200923
            [companyName] => PERRIGO ISRAEL
            [docInserts] => ["",""]
            [products] => [{"drugName":"GYNAZOLE-1","activeIngredients":"BUTOCONAZOLE NITRATE","strength":"2%","dosageForm":"CREAM;VAGINAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/18\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"06\/17\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Proprietary Name Change","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-06-17
        )

)