ANDA 088811

WOCKHARDT BIO AG

FDA Drug Application

Application #088811

Application Sponsors

ANDA 088811

WOCKHARDT BIO AG

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

2MG/5ML;10MG/5ML;30MG/5ML

0

BROMFED-DM

BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1985-06-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1987-05-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1987-05-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1988-08-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1989-04-05
LABELING; Labeling	SUPPL	6	AP	1989-05-10
LABELING; Labeling	SUPPL	8	AP	1991-08-19
LABELING; Labeling	SUPPL	9	AP	1994-03-04
LABELING; Labeling	SUPPL	10	AP	1999-01-12
LABELING; Labeling	SUPPL	13	AP	2004-09-30
LABELING; Labeling	SUPPL	18	AP	2016-06-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2016-06-03
LABELING; Labeling	SUPPL	26	AP	2016-06-03	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	18	Null	7
SUPPL	19	Null	7
SUPPL	26	Null	15

TE Codes

001

Prescription

AA

CDER Filings

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(
    [0] => Array
        (
            [ApplNo] => 88811
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)