ANDA 083149

NOVARTIS

FDA Drug Application

Application #083149

Application Sponsors

ANDA 083149

NOVARTIS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

25MG

0

PBZ

TRIPELENNAMINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1973-09-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1983-10-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1983-10-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1983-10-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1985-04-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1985-04-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1995-08-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1997-10-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1997-03-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1997-08-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1999-07-20

Submissions Property Types

SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83149
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)