Sanofi S.r.l.

Matched from indexed company URL: Sanofi, Inc.

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

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
04030685900001	My Dose Coach - 1.x.x	+496930523019	alexander.valenca@sanofi.com

sanofi.com

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#

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

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

Avalide

Sanofi-Aventis U.S. LLC

irbesartan and hydrochlorothiazide

Avalide

Sanofi-Aventis U.S. LLC

irbesartan and hydrochlorothiazide

MERILOG

Sanofi-Aventis U.S. LLC

insulin aspart-szjj

110 records. Showing 1-40. Next

PMA#

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...

51 records. Showing 1-40. Next

PMN#

My Dose Coach

2017-05-26

Sanofi

My Dose Coach

2017-03-22

Sanofi, Inc.

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

Sanofi S.r.l.

FDA Registration(s)#

GUDID Contact Samples#

Registered Device Listings#

Product Codes Associated With Registrations#

NDC#

PMA#

PMN#

Applications#

GUDID#