ANDA 070868

WOCKHARDT BIO AG

FDA Drug Application

Application #070868

Application Sponsors

ANDA 070868

WOCKHARDT BIO AG

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

250MG/5ML

0

VALPROIC ACID

VALPROIC ACID

FDA Submissions

	ORIG	1	AP	1986-07-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1987-04-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1987-06-15
LABELING; Labeling	SUPPL	5	AP	1989-01-11
LABELING; Labeling	SUPPL	6	AP	1993-11-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1999-05-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1999-05-04
LABELING; Labeling	SUPPL	9	AP	2002-05-24
LABELING; Labeling	SUPPL	10	AP	2003-03-21
LABELING; Labeling	SUPPL	12	AP	2004-03-10
LABELING; Labeling	SUPPL	14	AP	2006-12-15
LABELING; Labeling	SUPPL	15	AP	2010-01-06

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	15	Null	7

TE Codes

001

Prescription

AA

CDER Filings

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(
    [0] => Array
        (
            [ApplNo] => 70868
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)