ANDA 091553

PERRIGO ISRAEL

FDA Drug Application

Application #091553

Application Sponsors

ANDA 091553

PERRIGO ISRAEL

Marketing Status

• Prescription: 001

Application Products

001

LOTION;TOPICAL

0.05%

0

FLUTICASONE PROPIONATE

FLUTICASONE PROPIONATE

FDA Submissions

	ORIG	1	AP	2013-07-30
LABELING; Labeling	SUPPL	4	AP	2019-11-27	STANDARD
LABELING; Labeling	SUPPL	9	AP	2019-11-27	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	7
SUPPL	9	Null	7

TE Codes

001

Prescription

AB

CDER Filings

PERRIGO ISRAEL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91553
            [companyName] => PERRIGO ISRAEL
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUTICASONE PROPIONATE","activeIngredients":"FLUTICASONE PROPIONATE","strength":"0.05%","dosageForm":"LOTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLUTICASONE PROPIONATE","submission":"FLUTICASONE PROPIONATE","actionType":"0.05%","submissionClassification":"LOTION;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)