SANOFI

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3002807108	3002807108	Sanofi S.r.l.	1	N	2026-01-01	LOCALITA VALCANELLO ANAGNI Frosinone IT 03012
3003496686	3000719690	Sanofi-Aventis U.S. LLC	1	N	2020-04-25	55 Corporate Drive BRIDGEWATER NJ US 08807
3010770778	3010770778	Sanofi US Services Inc.	1	N	2020-04-25	270 Albany Street Cambridge MA US 02139

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
208219	1648798293	K171230	My Dose Coach	NDC	2017-05-26
208219	1158476131	K163099	My Dose Coach	NDC	2017-03-22
61505	1804950956	K131159	SMARTRELIEF	NUH	2013-07-25
21435	1488020870

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
NDC	2	2017-05-26
NUH	1	2013-07-25

NDC#

Sarclisa
Sanofi-Aventis U.S. LLC
isatuximab
Sarclisa
Sanofi-Aventis U.S. LLC
isatuximab
Plavix
Sanofi-Aventis U.S. LLC
clopidogrel
Plavix
Sanofi-Aventis U.S. LLC
clopidogrel
Primaquine Phosphate
Sanofi-Aventis U.S. LLC
Primaquine Phosphate
Ferrlecit
sanofi-aventis U.S. LLC
sodium ferric gluconate complex
Ferrlecit
sanofi-aventis U.S. LLC
sodium ferric gluconate complex
Multaq
Sanofi-Aventis U.S. LLC
Dronedarone
Fexinidazole
Sanofi-Aventis U.S. LLC
Fexinidazole
Elitek
Sanofi-Aventis U.S. LLC
rasburicase
Elitek
Sanofi-Aventis U.S. LLC
rasburicase
Ambien
Sanofi-Aventis U.S. LLC
zolpidem tartrate
Ambien
Sanofi-Aventis U.S. LLC
zolpidem tartrate
Ambien
Sanofi-Aventis U.S. LLC
zolpidem tartrate
Soliqua 100/33
Sanofi-Aventis U.S. LLC
insulin glargine and lixisenatide
Jevtana
Sanofi-Aventis U.S. LLC
cabazitaxel
ZALTRAP
sanofi-aventis U.S. LLC
ziv-aflibercept
ZALTRAP
sanofi-aventis U.S. LLC
ziv-aflibercept
Avapro
Sanofi-Aventis U.S. LLC
irbesartan
Avapro
Sanofi-Aventis U.S. LLC
irbesartan
Avalide
Sanofi-Aventis U.S. LLC
irbesartan and hydrochlorothiazide
Avalide
Sanofi-Aventis U.S. LLC
irbesartan and hydrochlorothiazide
Mozobil
Sanofi-Aventis U.S. LLC
PLERIXAFOR
TOUJEO
Sanofi-Aventis U.S. LLC
insulin glargine
TOUJEO Max
Sanofi-Aventis U.S. LLC
insulin glargine
Praluent
Sanofi-Aventis U.S. LLC
alirocumab
Praluent
Sanofi-Aventis U.S. LLC
alirocumab
KEVZARA
Sanofi-Aventis U.S. LLC
sarilumab
KEVZARA
Sanofi-Aventis U.S. LLC
sarilumab
Dupixent
Sanofi-Aventis U.S. LLC
Dupilumab
Dupixent
Sanofi-Aventis U.S. LLC
Dupilumab
Dupixent
Sanofi-Aventis U.S. LLC
Dupilumab
Dupixent
Sanofi-Aventis U.S. LLC
Dupilumab
Dupixent
Sanofi-Aventis U.S. LLC
Dupilumab
KEVZARA
Sanofi-Aventis U.S. LLC
sarilumab
KEVZARA
Sanofi-Aventis U.S. LLC
sarilumab
ADMELOG
Sanofi-Aventis U.S. LLC
insulin lispro
ADMELOG
Sanofi-Aventis U.S. LLC
insulin lispro
ADMELOG
Sanofi-Aventis U.S. LLC
insulin lispro
MERILOG
Sanofi-Aventis U.S. LLC
insulin aspart-szjj

110 records. Showing 1-40. Next

PMA#

Synvisc, Synvisc-One
2023-01-13
Sanofi GENZYME CORP.50 Binney Streetcambridge, MA 02142 PMA NumberP940015 Supplement NumberS051 Date Received12/16/2022 Decision Date01/13/2023 Product Code MOZ Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - M...
Synvisc and Synvisc-One
2022-11-04
Sanofi GENZYME CORP.50 Binney Streetcambridge, MA 02142 PMA NumberP940015 Supplement NumberS050 Date Received09/30/2022 Decision Date11/04/2022 Product Code MOZ Advisory Committee Orthopedic Supplement Typespecial (immediate Track) Supplement Reason Labeli...
Synvisc, Synvisc-One
2021-09-03
Sanofi GENZYME CORP.
Synvisc and Synvisc-One
2021-06-29
Sanofi GENZYME CORP.
Synvisc, Synvisc-One
2020-07-17
Sanofi GENZYME CORP.
Synvisc/Synvisc-One
2020-01-16
Sanofi GENZYME CORP.
Synvisc One
2019-01-16
Sanofi GENZYME CORP.
Synvisc and Synvisc-One
2019-01-10
Sanofi GENZYME CORP.
Synvisc One
2018-12-28
Sanofi GENZYME CORP.
Synvisc and Synvisc-One
2018-11-02
Sanofi GENZYME CORP.
SYNVISC ONE
2017-05-11
Sanofi GENZYME CORP.
Synvisc
2017-03-29
Sanofi GENZYME CORP.
SYNVISC
2017-01-18
Sanofi GENZYME CORP.
SYNVISC
2016-11-08
Sanofi GENZYME CORP.
SYNVISC ONE
2016-04-04
Sanofi GENZYME CORP.
SYNVISC, SYNVISC-ONE
2015-07-24
Sanofi GENZYME CORP.
SYNVISC
2015-05-26
Sanofi GENZYME CORP.
SYNVISC, SYNVISC-ONE
2014-08-21
Sanofi GENZYME CORP.
SYNVISC AND SYNVISC ONE
2014-08-06
Sanofi GENZYME CORP.
SYNVISC AND SYNVISC-ONE
2014-05-20
Sanofi GENZYME CORP.
SYNVISC
2014-05-14
Sanofi GENZYME CORP.
SYNVISC
2014-02-12
Sanofi GENZYME CORP.
SYNVISC
2013-12-05
Sanofi GENZYME CORP.
SYNVISC AND SYNVISC-ONE
2013-06-28
Sanofi GENZYME CORP.
SYNVISC AND SYNVISC-ONE
2012-06-22
Sanofi GENZYME CORP.
SYNVISC & SYNVISC-ONE
2012-05-03
Sanofi GENZYME CORP.
SYNVISC & SYNVISC-ONE
2012-01-05
Sanofi GENZYME CORP.
SYNVISC & SYNVISC-ONE (HYLAN G-F 20)
2011-10-07
Sanofi GENZYME CORP.
SYNVISC AND SYNVISC-ONE
2011-10-07
Sanofi GENZYME CORP.
SYNVISC AND SYNVISC-ONE
2011-07-07
Sanofi GENZYME CORP.
SYNVISC & SYNVISC-ONE
2011-03-18
Sanofi GENZYME CORP.
SYNVISC (HYLAN G-F 20) AND SYNVISC-ONE (HYLAN G-F 20)
2010-11-24
Sanofi GENZYME CORP.
SYNVISC & SYNVISC-ONE
2010-09-15
Sanofi GENZYME CORP.
SYNVISC-ONE (HYLAN G-F 20)
2010-03-12
Sanofi GENZYME CORP.
SYNVISC
2009-08-20
Sanofi GENZYME CORP.
SYNVISC
2009-04-10
Sanofi GENZYME CORP.
SYNVISC & SYNVISC-ONE (HYLAN G-F 20)
2009-03-11
Sanofi GENZYME CORP.
SYNVISC-ONE
2009-02-26
Sanofi GENZYME CORP.
SYNVISC HYLAN G-F 20
2008-06-09
Sanofi GENZYME CORP.
SYNVISC HYLAN G-F 20
2003-09-26
Sanofi GENZYME CORP.

51 records. Showing 1-40. Next

PMN#

My Dose Coach
2017-05-26
Sanofi
My Dose Coach
2017-03-22
Sanofi, Inc.

Applications#

761325
SANOFI-AVENTIS U.S. LLC
761113
SANOFI AVENTIS US
761037
SANOFI SYNTHELABO
209196
SANOFI-AVENTIS US
209090
SANOFI AVENTIS US
209089
SANOFI AVENTIS US
208673
SANOFI-AVENTIS US
208471
SANOFI-AVENTIS US
206538
SANOFI US SERVICES
202992
SANOFI AVENTIS US
201373
SANOFI AVENTIS US
201023
SANOFI AVENTIS US
125559
SANOFI AVENTIS
125418
SANOFI AVENTIS US
121559
SANOFI-AVENTIS US
103946
SANOFI SYNTHELABO
089540
SANOFI AVENTIS US
089539
SANOFI AVENTIS US
088746
SANOFI AVENTIS US
088269
SANOFI AVENTIS US
087894
SANOFI AVENTIS US
087893
SANOFI AVENTIS US
087892
SANOFI AVENTIS US
087260
SANOFI AVENTIS US
087091
SANOFI AVENTIS US
085264
SANOFI AVENTIS US
085206
SANOFI AVENTIS US
085205
SANOFI AVENTIS US
085204
SANOFI AVENTIS US
085203
SANOFI AVENTIS US
085202
SANOFI AVENTIS US
085187
SANOFI AVENTIS US
083823
SANOFI AVENTIS US
083518
SANOFI AVENTIS US
083517
SANOFI AVENTIS US
083459
SANOFI AVENTIS US
080564
SANOFI AVENTIS US
071159
SANOFI AVENTIS US
062659
SANOFI AVENTIS US
062303
SANOFI AVENTIS US

158 records. Showing 1-40. Next

GUDID#

My Dose Coach - 1.x.x
Sanofi-Aventis Deutschland GmbH
2017-06-02
My Dose Coach - Insulin Titration App
Sanofi-Aventis Deutschland GmbH
2020-11-23