NDA 050627

SANOFI AVENTIS US

FDA Drug Application

Application #050627

Documents

• Letter: 2004-08-25
• Letter: 2010-11-22
• Label: 2013-03-01
• Letter: 2013-03-01
• Label: 2004-08-25
• Label: 2010-11-12
• 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
• Letter: 2020-05-13
• Label: 2020-05-13
• Letter: 2021-06-22
• Label: 2021-06-23
• Label: 2021-10-22
• Letter: 2021-10-22
• Letter: 2022-01-31
• Label: 2022-02-02

Application Sponsors

NDA 050627

SANOFI AVENTIS US

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

600MG/VIAL

1

RIFADIN

RIFAMPIN

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1989-05-25	STANDARD
LABELING; Labeling	SUPPL	2	AP	1992-03-10
LABELING; Labeling	SUPPL	4	AP	1996-09-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1995-07-28	STANDARD
LABELING; Labeling	SUPPL	6	AP	2000-04-12	STANDARD
LABELING; Labeling	SUPPL	7	AP	2000-04-12	STANDARD
LABELING; Labeling	SUPPL	8	AP	2004-08-20	STANDARD
LABELING; Labeling	SUPPL	12	AP	2010-11-10	STANDARD
LABELING; Labeling	SUPPL	14	AP	2013-02-27	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2015-04-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2015-12-02	STANDARD
LABELING; Labeling	SUPPL	17	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	20	AP	2018-01-08	STANDARD
LABELING; Labeling	SUPPL	21	AP	2019-01-23	STANDARD
LABELING; Labeling	SUPPL	23	AP	2019-02-28	STANDARD
LABELING; Labeling	SUPPL	25	AP	2019-08-27	STANDARD
LABELING; Labeling	SUPPL	27	AP	2020-05-12	STANDARD
LABELING; Labeling	SUPPL	28	AP	2021-06-17	STANDARD
LABELING; Labeling	SUPPL	29	AP	2021-10-21	STANDARD
LABELING; Labeling	SUPPL	30	AP	2022-01-29	STANDARD

Submissions Property Types

ORIG	1	Orphan	5
SUPPL	5	Null	14
SUPPL	12	Null	7
SUPPL	14	Null	7
SUPPL	15	Null	14
SUPPL	16	Null	14
SUPPL	17	Null	6
SUPPL	20	Null	7
SUPPL	21	Null	15
SUPPL	23	Null	15
SUPPL	25	Null	7
SUPPL	27	Null	7
SUPPL	28	Null	15
SUPPL	29	Null	6
SUPPL	30	Null	6

TE Codes

001

Prescription

AP

CDER Filings

SANOFI AVENTIS US

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(
    [0] => Array
        (
            [ApplNo] => 50627
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"RIFADIN","activeIngredients":"RIFAMPIN","strength":"600MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/12\/2020","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/050420s084,050627s027lbl.pdf\"}]","notes":""},{"actionDate":"08\/27\/2019","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/050420s083,050627s025lbl.pdf\"}]","notes":""},{"actionDate":"02\/28\/2019","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/050420s080,050627s023lbl.pdf\"}]","notes":""},{"actionDate":"01\/23\/2019","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/050420s078,050627s021lbl.pdf\"}]","notes":""},{"actionDate":"01\/08\/2018","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/050420s077,050627s020lbl.pdf\"}]","notes":""},{"actionDate":"04\/24\/2017","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/050420s076,050627s017lbl.pdf\"}]","notes":"Please see"},{"actionDate":"02\/27\/2013","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/050420s075,050627s014lbl.pdf\"}]","notes":""},{"actionDate":"11\/10\/2010","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/050420s073,050627s012lbl.pdf\"}]","notes":""},{"actionDate":"08\/20\/2004","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/50420s072,50627s008lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"RIFADIN","submission":"RIFAMPIN","actionType":"600MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-05-12
        )

)