NDA 020786

SANOFI AVENTIS US

FDA Drug Application

Application #020786

Documents

• Letter: 2002-11-01
• Letter: 2003-06-08
• Letter: 2010-04-19
• Letter: 2012-02-13
• Letter: 2012-08-27
• Letter: 2012-12-11
• Letter: 2016-06-07
• Label: 2003-05-29
• Label: 2010-04-19
• Label: 2013-01-08
• Label: 2015-06-19
• Review: 2008-08-08
• Review: 2007-08-06
• Letter: 2011-01-27
• Letter: 2015-06-10
• Label: 2012-03-27
• Label: 2012-10-12
• Label: 2016-06-10
• Review: 2010-05-25
• Review: 2008-08-08
• Review: 2008-08-08
• Review: 2008-08-04
• Review: 2008-08-08
• Review: 2008-08-04
• Review: 2008-08-04

Application Sponsors

NDA 020786

SANOFI AVENTIS US

Marketing Status

• Over-the-counter: 002

Application Products

002

TABLET, EXTENDED RELEASE;ORAL

60MG;120MG

1

ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION

FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1997-12-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1999-12-21	STANDARD
LABELING; Labeling	SUPPL	3	AP	1998-12-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2000-01-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1999-12-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2000-01-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-09-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2001-01-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2002-10-29	STANDARD
LABELING; Labeling	SUPPL	12	AP	2002-11-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2001-10-31	STANDARD
EFFICACY; Efficacy	SUPPL	14	AP	2003-05-12	PRIORITY
LABELING; Labeling	SUPPL	17	AP	2004-12-06	STANDARD
LABELING; Labeling	SUPPL	26	AP	2010-04-14	UNKNOWN
EFFICACY; Efficacy	SUPPL	27	AP	2011-01-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2012-02-03	STANDARD
LABELING; Labeling	SUPPL	29	AP	2012-08-23	STANDARD
LABELING; Labeling	SUPPL	31	AP	2012-12-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	2014-05-14	STANDARD
EFFICACY; Efficacy	SUPPL	33	AP	2015-06-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	2015-07-09	STANDARD
LABELING; Labeling	SUPPL	35	AP	2016-06-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	2016-10-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	2016-10-31	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	6
SUPPL	26	Null	6
SUPPL	27	Null	6
SUPPL	28	Null	0
SUPPL	29	Null	15
SUPPL	31	Null	7
SUPPL	32	Null	0
SUPPL	33	Null	15
SUPPL	34	Null	0
SUPPL	35	Null	15

CDER Filings

SANOFI AVENTIS US

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20786
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION","activeIngredients":"FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE","strength":"60MG;120MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/02\/2016","submission":"SUPPL-35","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020786Origs035,021704Orig1s018lbl.pdf\"}]","notes":""},{"actionDate":"06\/08\/2015","submission":"SUPPL-33","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"12\/05\/2012","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020786s031lbl.pdf\"}]","notes":""},{"actionDate":"08\/23\/2012","submission":"SUPPL-29","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020786s029lbl.pdf\"}]","notes":""},{"actionDate":"01\/24\/2011","submission":"SUPPL-27","supplementCategories":"Efficacy-Rx To OTC Switch","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020786Orig1s027lbl.pdf\"}]","notes":""},{"actionDate":"04\/14\/2010","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020786s026lbl.pdf\"}]","notes":""},{"actionDate":"05\/12\/2003","submission":"SUPPL-14","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20786se8-014,20872se8-011,20625se8-012_allegra_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION","submission":"FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE","actionType":"60MG;120MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2016-06-02
        )

)