ANDA 087294

WOCKHARDT BIO AG

FDA Drug Application

Application #087294

Documents

• Letter: 2014-06-11
• Label: 2014-06-24

Application Sponsors

ANDA 087294

WOCKHARDT BIO AG

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

10MG/5ML

0

HYDROXYZINE HYDROCHLORIDE

HYDROXYZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1982-04-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1984-03-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1984-12-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1984-12-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1985-10-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1987-04-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1988-12-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1989-02-07
LABELING; Labeling	SUPPL	13	AP	1989-06-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1993-09-08
LABELING; Labeling	SUPPL	15	AP	1990-06-19
LABELING; Labeling	SUPPL	16	AP	1991-02-11
LABELING; Labeling	SUPPL	17	AP	1991-02-11
LABELING; Labeling	SUPPL	18	AP	1991-02-11
LABELING; Labeling	SUPPL	19	AP	1993-12-27
LABELING; Labeling	SUPPL	20	AP	2002-08-22
LABELING; Labeling	SUPPL	21	AP	2003-06-13
LABELING; Labeling	SUPPL	23	AP	2005-04-04
LABELING; Labeling	SUPPL	26	AP	2014-06-03	STANDARD
LABELING; Labeling	SUPPL	27	AP	2016-03-30	STANDARD
LABELING; Labeling	SUPPL	28	AP	2016-11-08	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	26	Null	7
SUPPL	27	Null	7
SUPPL	28	Null	15

TE Codes

001

Prescription

AA

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87294
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)