ANDA 088251

WOCKHARDT BIO AG

FDA Drug Application

Application #088251

Application Sponsors

ANDA 088251

WOCKHARDT BIO AG

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

2MG/5ML

0

DEXCHLORPHENIRAMINE MALEATE

DEXCHLORPHENIRAMINE MALEATE

FDA Submissions

	ORIG	1	AP	1984-03-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1985-01-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1986-04-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1987-04-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1987-04-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1988-08-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1989-04-05
LABELING; Labeling	SUPPL	10	AP	1989-10-24
LABELING; Labeling	SUPPL	11	AP	1991-04-10
LABELING; Labeling	SUPPL	12	AP	1991-09-18
LABELING; Labeling	SUPPL	13	AP	1993-08-04
LABELING; Labeling	SUPPL	14	AP	1994-04-12
LABELING; Labeling	SUPPL	15	AP	2004-04-20

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0

TE Codes

001

Prescription

AA

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88251
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)