ANDA 088759

TARO PHARM INDS LTD

FDA Drug Application

Application #088759

Application Sponsors

ANDA 088759

TARO PHARM INDS LTD

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OTIC

2%;1%

0

HYDROCORTISONE AND ACETIC ACID

ACETIC ACID, GLACIAL; HYDROCORTISONE

FDA Submissions

	ORIG	1	AP	1985-03-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1986-08-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1986-08-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1988-03-01
LABELING; Labeling	SUPPL	7	AP	1988-04-19
LABELING; Labeling	SUPPL	8	AP	1989-01-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1989-08-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1991-03-27
LABELING; Labeling	SUPPL	11	AP	1992-07-17
LABELING; Labeling	SUPPL	12	AP	1992-04-28
LABELING; Labeling	SUPPL	13	AP	1992-10-01
LABELING; Labeling	SUPPL	14	AP	1993-02-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1996-06-13
LABELING; Labeling	SUPPL	17	AP	1999-08-24
LABELING; Labeling	SUPPL	22	AP	2005-04-28

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	15	Null	0

TE Codes

001

Prescription

AT

CDER Filings

TARO PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88759
            [companyName] => TARO PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCORTISONE AND ACETIC ACID","activeIngredients":"ACETIC ACID, GLACIAL; HYDROCORTISONE","strength":"2%;1%","dosageForm":"SOLUTION\/DROPS;OTIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCORTISONE AND ACETIC ACID","submission":"ACETIC ACID, GLACIAL; HYDROCORTISONE","actionType":"2%;1%","submissionClassification":"SOLUTION\/DROPS;OTIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)