ANDA 071012

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #071012

Application Sponsors

ANDA 071012

ACTAVIS MID ATLANTIC

Marketing Status

• Prescription: 001

Application Products

001

OINTMENT;TOPICAL

EQ 0.05% BASE

0

BETAMETHASONE DIPROPIONATE

BETAMETHASONE DIPROPIONATE

FDA Submissions

	ORIG	1	AP	1987-02-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1989-09-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1993-01-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1995-09-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1995-09-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1996-05-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1996-05-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1996-05-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1996-05-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1996-02-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1996-06-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2000-12-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2001-05-30
LABELING; Labeling	SUPPL	14	AP	2003-01-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2015-03-30	UNKNOWN

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	21	Null	15

TE Codes

001

Prescription

AB

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 71012
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BETAMETHASONE DIPROPIONATE","activeIngredients":"BETAMETHASONE DIPROPIONATE","strength":"EQ 0.05% BASE","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BETAMETHASONE DIPROPIONATE","submission":"BETAMETHASONE DIPROPIONATE","actionType":"EQ 0.05% BASE","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)