NDA 050705

SANOFI AVENTIS US

FDA Drug Application

Application #050705

Documents

• Letter: 2005-05-02
• Letter: 2010-11-22
• Letter: 2013-03-01
• Label: 2005-05-02
• Label: 2009-01-02
• Letter: 2008-12-29
• Label: 2010-11-17
• Label: 2013-03-01
• Label: 2017-04-25
• Letter: 2017-04-27
• Label: 2018-01-09
• Letter: 2018-01-10
• Label: 2019-01-25
• Letter: 2019-02-13
• Letter: 2019-03-01
• Label: 2019-03-07
• Letter: 2019-08-28
• Label: 2019-08-28
• Label: 2020-05-13
• Letter: 2020-05-13
• Letter: 2021-06-22
• Label: 2021-06-23
• Letter: 2021-10-25
• Label: 2021-10-25
• Letter: 2022-01-31
• Label: 2022-02-02

Application Sponsors

NDA 050705

SANOFI AVENTIS US

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

50MG;300MG;120MG

1

RIFATER

ISONIAZID; PYRAZINAMIDE; RIFAMPIN

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1994-05-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1996-04-08	STANDARD
LABELING; Labeling	SUPPL	3	AP	2000-04-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2000-10-06	STANDARD
LABELING; Labeling	SUPPL	5	AP	2005-04-28	STANDARD
LABELING; Labeling	SUPPL	6	AP	2008-12-18	STANDARD
LABELING; Labeling	SUPPL	7	AP	2010-11-12	STANDARD
LABELING; Labeling	SUPPL	10	AP	2013-02-27	UNKNOWN
LABELING; Labeling	SUPPL	11	AP	2017-04-24	STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
LABELING; Labeling	SUPPL	12	AP	2018-01-08	STANDARD
LABELING; Labeling	SUPPL	13	AP	2019-01-23	STANDARD
LABELING; Labeling	SUPPL	15	AP	2019-02-28	STANDARD
LABELING; Labeling	SUPPL	17	AP	2019-08-27	STANDARD
LABELING; Labeling	SUPPL	18	AP	2020-05-12	STANDARD
LABELING; Labeling	SUPPL	19	AP	2021-06-17	STANDARD
LABELING; Labeling	SUPPL	20	AP	2021-10-21	STANDARD
LABELING; Labeling	SUPPL	21	AP	2022-01-29	STANDARD

Submissions Property Types

ORIG	1	Orphan	5
SUPPL	2	Null	14
SUPPL	4	Null	14
SUPPL	7	Null	6
SUPPL	10	Null	7
SUPPL	11	Null	7
SUPPL	12	Null	15
SUPPL	13	Null	6
SUPPL	15	Null	15
SUPPL	17	Null	7
SUPPL	18	Null	15
SUPPL	19	Null	6
SUPPL	20	Null	6
SUPPL	21	Null	7

CDER Filings

SANOFI AVENTIS US

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50705
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"RIFATER","activeIngredients":"ISONIAZID; PYRAZINAMIDE; RIFAMPIN","strength":"50MG;300MG;120MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/12\/2020","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/050705s018lbl.pdf\"}]","notes":""},{"actionDate":"08\/27\/2019","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/050705s017lbl.pdf\"}]","notes":""},{"actionDate":"02\/28\/2019","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/050705s015lbl.pdf\"}]","notes":""},{"actionDate":"01\/23\/2019","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/050705s013lbl.pdf\"}]","notes":""},{"actionDate":"01\/08\/2018","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/050705s012lbl.pdf\"}]","notes":""},{"actionDate":"04\/24\/2017","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/050705s011lbl.pdf\"}]","notes":"Please see"},{"actionDate":"02\/27\/2013","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/050705s010lbl.pdf\"}]","notes":""},{"actionDate":"11\/12\/2010","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/050705s007lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2008","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/050705s006lbl.pdf\"}]","notes":""},{"actionDate":"04\/28\/2005","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/050705s005lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"RIFATER","submission":"ISONIAZID; PYRAZINAMIDE; RIFAMPIN","actionType":"50MG;300MG;120MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-05-12
        )

)