ANDA 040420

WOCKHARDT BIO AG

FDA Drug Application

Application #040420

Documents

• Letter: 2003-04-09
• Review: 2006-04-20

Application Sponsors

ANDA 040420

WOCKHARDT BIO AG

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

125MG/5ML

0

PHENYTOIN

PHENYTOIN

FDA Submissions

	ORIG	1	AP	2002-04-19
LABELING; Labeling	SUPPL	2	AP	2002-11-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-11-06
LABELING; Labeling	SUPPL	4	AP	2003-12-09
LABELING; Labeling	SUPPL	5	AP	2005-04-20
LABELING; Labeling	SUPPL	9	AP	2010-02-02

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	9	Null	7

TE Codes

001

Prescription

AB

CDER Filings

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        (
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            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
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            [supplements] => 
            [actionDate] => 0000-00-00
        )

)