NDA 018733

SANOFI AVENTIS US

FDA Drug Application

Application #018733

Documents

• Letter: 2003-03-10
• Label: 2008-09-12
• Letter: 2011-03-02
• Label: 2011-03-04

Application Sponsors

NDA 018733

SANOFI AVENTIS US

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

EQ 0.5MG BASE;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

0

TALWIN NX

NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1982-12-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1983-04-05	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1983-04-05	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1983-04-05	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1983-04-05	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1983-04-05	PRIORITY
LABELING; Labeling	SUPPL	7	AP	1989-01-12	PRIORITY
LABELING; Labeling	SUPPL	8	AP	1985-10-09	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1987-02-02	PRIORITY
LABELING; Labeling	SUPPL	10	AP	1989-01-12	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1988-02-29	PRIORITY
LABELING; Labeling	SUPPL	12	AP	2003-02-26	PRIORITY
LABELING; Labeling	SUPPL	14	AP	2008-09-01	PRIORITY
LABELING; Labeling	SUPPL	15	AP	2011-02-24	PRIORITY

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0

CDER Filings

SANOFI AVENTIS US

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18733
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"TALWIN NX","activeIngredients":"NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE","strength":"EQ 0.5MG BASE;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"02\/24\/2011","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/018733s015lbl.pdf\"}]","notes":""},{"actionDate":"09\/01\/2008","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/018733s014lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TALWIN NX","submission":"NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE","actionType":"EQ 0.5MG BASE;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2011-02-24
        )

)