NDA 017702

INTL MEDICATION

FDA Drug Application

Application #017702

Application Sponsors

NDA 017702

INTL MEDICATION

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	20%	0	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	LIDOCAINE HYDROCHLORIDE
002	INJECTABLE;INJECTION	4%	0	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	LIDOCAINE HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1976-12-20	STANDARD
LABELING; Labeling	SUPPL	2	AP	1977-08-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1978-07-11	STANDARD
LABELING; Labeling	SUPPL	4	AP	1978-07-11
LABELING; Labeling	SUPPL	10	AP	1986-06-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1993-05-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1992-06-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1992-06-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1992-12-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1993-02-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1992-11-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1992-12-11	STANDARD
LABELING; Labeling	SUPPL	24	AP	1993-10-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1995-10-18	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	25	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17702
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)