ANDA 075027

PERRIGO CO

FDA Drug Application

Application #075027

Application Sponsors

ANDA 075027

PERRIGO CO

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

0.05%

0

CLOBETASOL PROPIONATE

CLOBETASOL PROPIONATE

FDA Submissions

	ORIG	1	AP	1997-10-31
LABELING; Labeling	SUPPL	2	AP	2000-07-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2000-12-20
LABELING; Labeling	SUPPL	4	AP	2000-12-20
LABELING; Labeling	SUPPL	5	AP	2007-11-28

Submissions Property Types

SUPPL

3

Null

0

TE Codes

001

Prescription

AB

CDER Filings

PERRIGO CO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75027
            [companyName] => PERRIGO CO
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLOBETASOL PROPIONATE","activeIngredients":"CLOBETASOL PROPIONATE","strength":"0.05%","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CLOBETASOL PROPIONATE","submission":"CLOBETASOL PROPIONATE","actionType":"0.05%","submissionClassification":"GEL;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)