ANDA 087796

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #087796

Application Sponsors

ANDA 087796

ACTAVIS MID ATLANTIC

Marketing Status

• Discontinued: 001

Application Products

001

OINTMENT;TOPICAL

1%

0

HYDROCORTISONE

HYDROCORTISONE

FDA Submissions

	ORIG	1	AP	1982-10-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1986-06-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1986-06-12
LABELING; Labeling	SUPPL	6	AP	1993-05-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1989-07-26
LABELING; Labeling	SUPPL	8	AP	1992-03-04
LABELING; Labeling	SUPPL	9	AP	1994-02-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1995-02-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1996-02-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1996-06-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1999-03-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2000-12-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2001-04-26

Submissions Property Types

SUPPL	1	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87796
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCORTISONE","activeIngredients":"HYDROCORTISONE","strength":"1%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCORTISONE","submission":"HYDROCORTISONE","actionType":"1%","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)