ANDA 075060

WOCKHARDT BIO AG

FDA Drug Application

Application #075060

Documents

• Letter: 1998-12-24

Application Sponsors

ANDA 075060

WOCKHARDT BIO AG

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

50MG/5ML

0

AMANTADINE HYDROCHLORIDE

AMANTADINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1998-12-24
LABELING; Labeling	SUPPL	2	AP	2007-01-12
LABELING; Labeling	SUPPL	3	AP	2007-09-14
LABELING; Labeling	SUPPL	5	AP	2011-08-31

Submissions Property Types

SUPPL	1	Null	0
SUPPL	5	Null	15

TE Codes

001

Prescription

AA

CDER Filings

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(
    [0] => Array
        (
            [ApplNo] => 75060
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)