ANDA 086364

INTL MEDICATION

FDA Drug Application

Application #086364

Application Sponsors

ANDA 086364

INTL MEDICATION

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;TOPICAL

4%

0

LARYNG-O-JET KIT

LIDOCAINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1980-03-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1982-10-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1982-11-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1985-08-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1985-11-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1987-10-19
LABELING; Labeling	SUPPL	18	AP	1989-08-29
LABELING; Labeling	SUPPL	19	AP	1992-09-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1993-03-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1993-10-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1998-01-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1994-06-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1995-09-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1997-12-17
LABELING; Labeling	SUPPL	35	AP	2015-08-18	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	10	Null	0
SUPPL	16	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	35	Null	7

TE Codes

001

Prescription

AT

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86364
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)