ANDA 088191

WOCKHARDT BIO AG

FDA Drug Application

Application #088191

Documents

• Other Important Information from FDA: 2003-12-17

Application Sponsors

ANDA 088191

WOCKHARDT BIO AG

Marketing Status

• Prescription: 001

Application Products

001

SHAMPOO;TOPICAL

1%

0

LINDANE

LINDANE

FDA Submissions

	ORIG	1	AP	1984-09-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1984-11-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1984-11-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1986-09-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1986-07-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1987-05-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1987-05-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1987-06-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1987-06-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1988-08-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1989-02-22
LABELING; Labeling	SUPPL	18	AP	1989-10-24
LABELING; Labeling	SUPPL	20	AP	1994-08-02
LABELING; Labeling	SUPPL	21	AP	1995-06-28
LABELING; Labeling	SUPPL	22	AP	1997-03-27
LABELING; Labeling	SUPPL	25	AP	2007-08-22

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	21	Null	1

TE Codes

001

Prescription

AT

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88191
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)