ANDA 071202

FRESENIUS KABI USA

FDA Drug Application

Application #071202

Application Sponsors

ANDA 071202

FRESENIUS KABI USA

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;SPINAL

0.75%

0

SENSORCAINE

BUPIVACAINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1987-04-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1992-09-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1996-06-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1995-08-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1996-04-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1996-05-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1997-04-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2002-12-23
LABELING; Labeling	SUPPL	10	AP	2005-07-21
LABELING; Labeling	SUPPL	12	AP	2010-06-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2012-06-30
LABELING; Labeling	SUPPL	16	AP	2012-12-11	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	12	Null	7
SUPPL	14	Null	15
SUPPL	16	Null	15

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 71202
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)