ANDA 078223

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #078223

Documents

• Letter: 2008-12-11
• Review: 2013-04-18

Application Sponsors

ANDA 078223

ACTAVIS MID ATLANTIC

Marketing Status

• Prescription: 001

Application Products

001

LOTION;TOPICAL

0.05%

0

CLOBETASOL PROPIONATE

CLOBETASOL PROPIONATE

FDA Submissions

	ORIG	1	AP	2008-12-04
LABELING; Labeling	SUPPL	9	AP	2015-06-29	STANDARD

Submissions Property Types

SUPPL

9

Null

7

TE Codes

001

Prescription

AB

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78223
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLOBETASOL PROPIONATE","activeIngredients":"CLOBETASOL PROPIONATE","strength":"0.05%","dosageForm":"LOTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CLOBETASOL PROPIONATE","submission":"CLOBETASOL PROPIONATE","actionType":"0.05%","submissionClassification":"LOTION;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)