ANDA 040313

WOCKHARDT BIO AG

FDA Drug Application

Application #040313

Application Sponsors

ANDA 040313

WOCKHARDT BIO AG

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

15MG/5ML

0

PREDNISOLONE

PREDNISOLONE

FDA Submissions

	ORIG	1	AP	2003-09-10
LABELING; Labeling	SUPPL	2	AP	2005-04-14

TE Codes

001

Prescription

AA

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40313
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)