ANDA 088008

WOCKHARDT BIO AG

FDA Drug Application

Application #088008

Application Sponsors

ANDA 088008

WOCKHARDT BIO AG

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

1.5MG/5ML;5MG/5ML

0

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE

HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE

FDA Submissions

	ORIG	1	AP	1983-03-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1986-12-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1987-02-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1987-02-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1987-02-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1988-07-28
LABELING; Labeling	SUPPL	7	AP	1988-10-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1989-04-05
LABELING; Labeling	SUPPL	9	AP	1989-07-12
LABELING; Labeling	SUPPL	10	AP	1989-07-12
LABELING; Labeling	SUPPL	11	AP	1989-12-27
LABELING; Labeling	SUPPL	12	AP	1994-03-25
LABELING; Labeling	SUPPL	13	AP	1996-05-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1996-02-13
LABELING; Labeling	SUPPL	17	AP	2017-01-13	STANDARD
LABELING; Labeling	SUPPL	18	AP	2018-06-28	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	14	Null	0
SUPPL	17	Null	7
SUPPL	18	Null	7

TE Codes

001

Prescription

AA

CDER Filings

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    [0] => Array
        (
            [ApplNo] => 88008
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)