ANDA 088638

TARO

FDA Drug Application

Application #088638

Application Sponsors

ANDA 088638

TARO

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OTIC

2%

0

ACETIC ACID

ACETIC ACID, GLACIAL

FDA Submissions

	ORIG	1	AP	1984-09-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1984-11-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1984-11-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1985-12-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1986-08-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1988-03-01
LABELING; Labeling	SUPPL	10	AP	1988-08-11
LABELING; Labeling	SUPPL	11	AP	1988-08-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1989-08-31
LABELING; Labeling	SUPPL	13	AP	1989-12-20
LABELING; Labeling	SUPPL	14	AP	1993-03-15
LABELING; Labeling	SUPPL	15	AP	1993-04-06
LABELING; Labeling	SUPPL	16	AP	1999-11-22
LABELING; Labeling	SUPPL	17	AP	2001-04-30

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	12	Null	0

TE Codes

001

Prescription

AT

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88638
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)