ANDA 088875

WOCKHARDT BIO AG

FDA Drug Application

Application #088875

Application Sponsors

ANDA 088875

WOCKHARDT BIO AG

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

10MG/5ML;6.25MG/5ML

0

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1984-12-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1986-03-05
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	8	AP	1987-04-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1988-08-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1989-04-05
LABELING; Labeling	SUPPL	15	AP	1990-01-31
LABELING; Labeling	SUPPL	16	AP	1990-08-23
LABELING; Labeling	SUPPL	17	AP	1991-01-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2002-06-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2002-06-27
LABELING; Labeling	SUPPL	26	AP	2002-06-27
LABELING; Labeling	SUPPL	29	AP	2006-04-03
LABELING; Labeling	SUPPL	30	AP	2008-02-25
LABELING; Labeling	SUPPL	31	AP	2008-12-19
LABELING; Labeling	SUPPL	32	AP	2010-01-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	2015-10-29	UNKNOWN
LABELING; Labeling	SUPPL	35	AP	2013-05-10	STANDARD
LABELING; Labeling	SUPPL	37	AP	2017-01-13	STANDARD
LABELING; Labeling	SUPPL	38	AP	2017-11-17	STANDARD
LABELING; Labeling	SUPPL	39	AP	2018-06-28	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	32	Null	7
SUPPL	34	Null	15
SUPPL	35	Null	7
SUPPL	37	Null	15
SUPPL	38	Null	7
SUPPL	39	Null	7

TE Codes

001

Prescription

AA

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88875
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)