ANDA 083173

INTL MEDICATION

FDA Drug Application

Application #083173

Application Sponsors

ANDA 083173

INTL MEDICATION

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	1%	0	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE
002	INJECTABLE;INJECTION	2%	0	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1975-09-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1986-05-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1986-03-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1987-06-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1987-07-10
LABELING; Labeling	SUPPL	14	AP	1993-10-19
LABELING; Labeling	SUPPL	18	AP	1992-12-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1992-12-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1991-11-26
LABELING; Labeling	SUPPL	21	AP	1991-06-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1992-10-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1993-02-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1993-07-08
LABELING; Labeling	SUPPL	26	AP	1993-07-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1992-12-17
LABELING; Labeling	SUPPL	28	AP	1993-04-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1993-10-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1998-01-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1994-06-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1994-06-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1995-09-19
LABELING; Labeling	SUPPL	34	AP	2001-04-06
LABELING; Labeling	SUPPL	36	AP	2005-09-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	2002-09-19
LABELING; Labeling	SUPPL	45	AP	2021-04-21	STANDARD

Submissions Property Types

SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	13	Null	0
SUPPL	18	Null	1
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	22	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	1
SUPPL	27	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	37	Null	0
SUPPL	45	Null	15

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83173
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)