ANDA 062512

WOCKHARDT BIO AG

FDA Drug Application

Application #062512

Application Sponsors

ANDA 062512

WOCKHARDT BIO AG

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

100,000 UNITS/ML

0

NYSTATIN

NYSTATIN

FDA Submissions

	ORIG	1	AP	1984-10-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1989-01-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1992-03-25
LABELING; Labeling	SUPPL	11	AP	1994-03-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1994-09-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1994-10-20
LABELING; Labeling	SUPPL	14	AP	1996-09-03
LABELING; Labeling	SUPPL	15	AP	1997-07-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2002-03-20

Submissions Property Types

SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	16	Null	0

TE Codes

001

Prescription

AA

CDER Filings

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(
    [0] => Array
        (
            [ApplNo] => 62512
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)