ANDA 089472

TARO

FDA Drug Application

Application #089472

Application Sponsors

ANDA 089472

TARO

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

1%;10%

0

U-CORT

HYDROCORTISONE ACETATE; UREA

FDA Submissions

	ORIG	1	AP	1988-06-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1990-04-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1989-10-10
LABELING; Labeling	SUPPL	6	AP	1992-09-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1997-04-24
LABELING; Labeling	SUPPL	8	AP	1997-04-24
LABELING; Labeling	SUPPL	19	AP	2006-10-04
LABELING; Labeling	SUPPL	22	AP	2006-06-07
LABELING; Labeling	SUPPL	23	AP	2013-06-17

Submissions Property Types

SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	7	Null	0
SUPPL	23	Null	15

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89472
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)