ANDA 077763

PERRIGO ISRAEL

FDA Drug Application

Application #077763

Documents

• Letter: 2008-03-11

Application Sponsors

ANDA 077763

PERRIGO ISRAEL

Marketing Status

• Prescription: 001

Application Products

001

AEROSOL, FOAM;TOPICAL

0.05%

0

CLOBETASOL PROPIONATE

CLOBETASOL PROPIONATE

FDA Submissions

	ORIG	1	AP	2008-03-10
LABELING; Labeling	SUPPL	11	AP	2019-11-14	STANDARD
LABELING; Labeling	SUPPL	13	AP	2019-11-14	STANDARD

Submissions Property Types

SUPPL	11	Null	15
SUPPL	13	Null	15

TE Codes

001

Prescription

AB1

CDER Filings

PERRIGO ISRAEL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77763
            [companyName] => PERRIGO ISRAEL
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLOBETASOL PROPIONATE","activeIngredients":"CLOBETASOL PROPIONATE","strength":"0.05%","dosageForm":"AEROSOL, FOAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CLOBETASOL PROPIONATE","submission":"CLOBETASOL PROPIONATE","actionType":"0.05%","submissionClassification":"AEROSOL, FOAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)