ANDA 088864

WOCKHARDT BIO AG

FDA Drug Application

Application #088864

Application Sponsors

ANDA 088864

WOCKHARDT BIO AG

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

15MG/5ML;6.25MG/5ML

0

PROMETHAZINE W/ DEXTROMETHORPHAN

DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1985-01-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1986-06-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1987-04-07
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	6	AP	1987-04-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1987-04-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1988-08-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1989-04-05
LABELING; Labeling	SUPPL	14	AP	1989-06-19
LABELING; Labeling	SUPPL	15	AP	1990-08-24
LABELING; Labeling	SUPPL	16	AP	1991-10-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1997-07-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1997-07-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1997-07-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1997-07-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1997-07-09
LABELING; Labeling	SUPPL	23	AP	1997-07-09
LABELING; Labeling	SUPPL	27	AP	2006-06-07

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0

TE Codes

001

Prescription

AA

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88864
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)