ANDA 087953

WOCKHARDT BIO AG

FDA Drug Application

Application #087953

Application Sponsors

ANDA 087953

WOCKHARDT BIO AG

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

6.25MG/5ML

0

PROMETHAZINE PLAIN

PROMETHAZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1982-11-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1985-02-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1985-02-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1985-02-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1985-02-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1985-02-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1985-02-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1987-03-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1989-03-15
LABELING; Labeling	SUPPL	18	AP	1990-01-19
LABELING; Labeling	SUPPL	19	AP	1991-01-18
LABELING; Labeling	SUPPL	20	AP	1992-02-11
LABELING; Labeling	SUPPL	21	AP	1994-08-10
LABELING; Labeling	SUPPL	22	AP	1995-06-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2000-02-17
LABELING; Labeling	SUPPL	29	AP	2000-02-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	2000-02-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	2000-02-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	2000-02-17
LABELING; Labeling	SUPPL	35	AP	2005-12-21
LABELING; Labeling	SUPPL	36	AP	2006-04-04

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	11	Null	0
SUPPL	17	Null	0
SUPPL	28	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0

TE Codes

001

Prescription

AA

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87953
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)