Sanofi

FDA Filings

This page includes the latest FDA filings for Sanofi. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FRANCE

EURONEXT PARIS

SAN

DUNS 739980787

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
Dinoprost Tromethamine EUROAPI Hungary Ltd., Sanofi	Other Medication	2022-03-22
Eprinomectine EUROAPI France, EUROAPI	Other Medication	2022-03-19
Eprinomectine EUROAPI France, EUROAPI	Other Medication	2022-03-19
Altrenogest EUROAPI France, EUROAPI	Other Medication	2022-03-18
Eprinomectine EUROAPI France, EUROAPI	Other Medication	2022-02-08
Altrenogest EUROAPI France, EUROAPI	Other Medication	2022-02-08
Altrenogest EUROAPI France, EUROAPI	Other Medication	2021-12-16
Eprinomectine EUROAPI France, EUROAPI	Other Medication	2021-11-18
Eprinomectine EUROAPI France, EUROAPI	Other Medication	2021-11-18
Dinoprost Tromethamine EUROAPI Hungary Ltd., Sanofi	Other Medication	2021-11-06
PMN K171230 Sanofi	My Dose Coach	2017-05-26
022127 NDA SANOFI		0000-00-00 00:00:00
021027 NDA SANOFI		0000-00-00 00:00:00
020862 NDA SANOFI		0000-00-00 00:00:00

Similar & Related FDA Registered Companies

• SANOFI AVENTIS U.S. LLC
• Sanofi Aventis
• Sanofi, Inc.
• 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 - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• 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 Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• Sanofi GENZYME CORP.
• Sanofi Chimie
• Sanofi Pasteur
• Sanofi Pasteur Inc.
• Sanofi Pasteur Limited
• Sanofi Pasteur NVL
• Sanofi Pasteur SA
• Sanofi Pasteur VDR
• Sanofi S.p.A
• Sanofi S.p.A (also known as Sanofi-Aventis S.p.A)
• Sanofi S.p.A (Anagni)
• Sanofi S.r.l (Anagni)
• Sanofi S.r.l.
• EUROAPI Hungary Ltd.
• EUROAPI France
• EUROAPI
• Sanofi-Aventis Deutschland GmbH

Related Finance Registrations

NCAGE Code	F3361	SANOFI
CAGE Code	F3361	SANOFI
SEC	0001121404	Sanofi of FRANCE

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
202007226970	Anvers,Belgium -> Houston, Texas	GLYCINE HTS 29.22.49.43	7 PAL
2020070334103	Anvers,Belgium -> Charleston, South Carolina	GLYCINE HTS 29.22.49.43	7 PAL
2020070247123	Anvers,Belgium -> Charleston, South Carolina	GLYCINE HTS 29.22.49.43	7 PAL
2020070137564	Anvers,Belgium -> Charleston, South Carolina	GLYCINE HTS 29.22.49.43	7 PAL
2020062745948	Anvers,Belgium -> Charleston, South Carolina	GLYCINE HTS 29.22.49.43	7 PAL
2020061657052	Le Havre,France -> New York/Newark Area, Newark, New Jersey	------------ TGBU5810123 DESCRIPTION--------- 80 CARTONS 462 KGM 4.14 MTQ 3 FILMED PALETTE PHARMA PRODUCTS 3 PALS STC 80 CTS	80 PCS
2020061657047	Le Havre,France -> New York/Newark Area, Newark, New Jersey	------------ TGBU5810123 DESCRIPTION--------- 231 PACKAGE (S) 972 KGM 8.858 MTQ DETAILED: 1 BOX MEDICAL PRODUCTS	231 PCS
2019060635225	Anvers,Belgium -> Houston, Texas	GLYCINE USP	2 PAL