ANDA 070639

INTL MEDICATION

FDA Drug Application

Application #070639

Application Sponsors

ANDA 070639

INTL MEDICATION

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

0.4MG/ML

0

NALOXONE HYDROCHLORIDE

NALOXONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1986-01-17
LABELING; Labeling	SUPPL	2	AP	1986-09-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1987-02-06
LABELING; Labeling	SUPPL	4	AP	1988-05-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1993-10-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1998-01-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1994-06-17
LABELING; Labeling	SUPPL	10	AP	1995-02-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1995-09-19
LABELING; Labeling	SUPPL	12	AP	1996-06-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2002-07-18
LABELING; Labeling	SUPPL	14	AP	2002-07-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2015-05-29
LABELING; Labeling	SUPPL	17	AP	2013-07-26	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	16	Null	7
SUPPL	17	Null	7

TE Codes

001

Prescription

AP

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70639
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)