NDA 018458

SANOFI AVENTIS US

FDA Drug Application

Application #018458

Documents

• Letter: 2008-08-12
• Letter: 2011-06-28
• Label: 2011-06-29
• Letter: 2003-07-28
• Letter: 2011-03-08
• Label: 2011-03-07

Application Sponsors

NDA 018458

SANOFI AVENTIS US

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

650MG;EQ 25MG BASE

0

TALACEN

ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1982-09-23	STANDARD
LABELING; Labeling	SUPPL	2	AP	1984-06-26	STANDARD
LABELING; Labeling	SUPPL	3	AP	1985-05-07	STANDARD
LABELING; Labeling	SUPPL	4	AP	1985-10-25	STANDARD
LABELING; Labeling	SUPPL	5	AP	1987-03-27	STANDARD
LABELING; Labeling	SUPPL	6	AP	1987-05-22	STANDARD
LABELING; Labeling	SUPPL	7	AP	1988-11-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1988-03-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2000-03-30	STANDARD
LABELING; Labeling	SUPPL	10	AP	2000-10-31	STANDARD
LABELING; Labeling	SUPPL	12	AP	2003-07-10	STANDARD
LABELING; Labeling	SUPPL	13	AP	2008-08-07	STANDARD
LABELING; Labeling	SUPPL	14	AP	2011-03-10	STANDARD
LABELING; Labeling	SUPPL	16	AP	2011-06-22	STANDARD

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	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0

CDER Filings

SANOFI AVENTIS US

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18458
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"TALACEN","activeIngredients":"ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE","strength":"650MG;EQ 25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/22\/2011","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/018458s016lbl.pdf\"}]","notes":""},{"actionDate":"03\/10\/2011","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/018458s014lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TALACEN","submission":"ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE","actionType":"650MG;EQ 25MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2011-06-22
        )

)