ANDA 088799

TARO PHARM INDS LTD

FDA Drug Application

Application #088799

Application Sponsors

ANDA 088799

TARO PHARM INDS LTD

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

2.5%

0

HYDROCORTISONE

HYDROCORTISONE

FDA Submissions

	ORIG	1	AP	1984-11-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1985-12-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1986-07-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1990-03-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1990-03-28
LABELING; Labeling	SUPPL	10	AP	1989-05-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1989-07-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1989-07-13
LABELING; Labeling	SUPPL	13	AP	1990-12-17
LABELING; Labeling	SUPPL	14	AP	1992-02-21
LABELING; Labeling	SUPPL	16	AP	1992-11-16
LABELING; Labeling	SUPPL	25	AP	1993-04-29
LABELING; Labeling	SUPPL	27	AP	2005-07-28
LABELING; Labeling	SUPPL	30	AP	2005-04-28

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0

TE Codes

001

Prescription

AT

CDER Filings

TARO PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88799
            [companyName] => TARO PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCORTISONE","activeIngredients":"HYDROCORTISONE","strength":"2.5%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCORTISONE","submission":"HYDROCORTISONE","actionType":"2.5%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)