ANDA 088228

WOCKHARDT BIO AG

FDA Drug Application

Application #088228

Application Sponsors

ANDA 088228

WOCKHARDT BIO AG

Marketing Status

• Prescription: 001

Application Products

001

LOTION/SHAMPOO;TOPICAL

2.5%

0

SELENIUM SULFIDE

SELENIUM SULFIDE

FDA Submissions

	ORIG	1	AP	1983-09-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1986-12-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1987-05-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1987-05-18
LABELING; Labeling	SUPPL	10	AP	1990-11-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1998-05-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1998-05-06

Submissions Property Types

SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0

TE Codes

001

Prescription

AT

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88228
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)