ANDA 086283

INTL MEDICATION

FDA Drug Application

Application #086283

Application Sponsors

ANDA 086283

INTL MEDICATION

Marketing Status

• Prescription: 001

Application Products

001

JELLY;TOPICAL

2%

0

LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1979-08-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1986-05-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1986-05-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1987-03-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1987-07-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1993-02-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1992-12-17
LABELING; Labeling	SUPPL	14	AP	1993-08-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1994-06-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1995-09-19

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0

TE Codes

001

Prescription

AT

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86283
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)