ANDA 074603

WOCKHARDT BIO AG

FDA Drug Application

Application #074603

Application Sponsors

ANDA 074603

WOCKHARDT BIO AG

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL, RECTAL

10GM/15ML

0

GENERLAC

LACTULOSE

FDA Submissions

	ORIG	1	AP	1996-10-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2000-04-14
LABELING; Labeling	SUPPL	3	AP	1999-07-15
LABELING; Labeling	SUPPL	4	AP	2001-04-05
LABELING; Labeling	SUPPL	5	AP	2001-11-26

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0

TE Codes

001

Prescription

AA

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74603
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)