ANDA 086257

TARO

FDA Drug Application

Application #086257

Application Sponsors

ANDA 086257

TARO

Marketing Status

• Prescription: 001

Application Products

001

OINTMENT;TOPICAL

1%

0

HYDROCORTISONE

HYDROCORTISONE

FDA Submissions

	ORIG	1	AP	1978-07-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1982-05-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1984-07-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1983-08-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1985-04-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1986-07-24
LABELING; Labeling	SUPPL	18	AP	1988-04-11
LABELING; Labeling	SUPPL	20	AP	1989-02-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1989-07-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1990-11-21
LABELING; Labeling	SUPPL	23	AP	1991-04-16
LABELING; Labeling	SUPPL	24	AP	1992-10-19
LABELING; Labeling	SUPPL	25	AP	1993-04-29

Submissions Property Types

SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	12	Null	0
SUPPL	15	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0

TE Codes

001

Prescription

AT

CDER Filings

TARO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86257
            [companyName] => TARO
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCORTISONE","activeIngredients":"HYDROCORTISONE","strength":"1%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCORTISONE","submission":"HYDROCORTISONE","actionType":"1%","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)