ANDA 076002

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #076002

Application Sponsors

ANDA 076002

ACTAVIS MID ATLANTIC

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

EQ 0.05% BASE;1%

0

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE

BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE

FDA Submissions

	ORIG	1	AP	2002-08-02
LABELING; Labeling	SUPPL	4	AP	2004-10-20
LABELING; Labeling	SUPPL	7	AP	2008-05-13
LABELING; Labeling	SUPPL	17	AP	2017-01-23	STANDARD
LABELING; Labeling	SUPPL	21	AP	2020-07-06	STANDARD

Submissions Property Types

SUPPL	17	Null	15
SUPPL	21	Null	7

TE Codes

001

Prescription

AB

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76002
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE","activeIngredients":"BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE","strength":"EQ 0.05% BASE;1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE","submission":"BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE","actionType":"EQ 0.05% BASE;1%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)