Sandoz G M B H

FDA Filings

This page includes the latest FDA filings for Sandoz G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

Registration Number

3004828473

FEI Number

3004828473

Name

Sandoz GmbH

Owner & Operator

Sandoz Inc

Contact Address

100 College Road West
Princeton NJ 08540 US

Official Correspondent

Gregory Seitz
x-609-6278515-x

US Agent

Gregory Seitz
SANDOZ INC.
609 6278515
gregory.seitz@sandoz.com

Importing Logistics Registration

Importer	SANDOZ INC.
	110342024
Address	2555 W MIDWAY BLVD Broomfield, CO 80020 UNITED STATES
Email Address	jean.domenico@sandoz.com
Phone	1 303 4384242
Importer Type	Agent

Registration Status

Initial Importer

Registration Expiration

2020-04-25

Registration Address

Biochemiestrasse 10
Langkampfen Tirol, 6336 AT

Establishment Type

Manufacture Medical Device

FDA Filings

Device Company	Device	Date
Amoxicillin and Clavulanate Potassium Bionpharma Inc., Sandoz GmbH	Prescription Medication	2025-07-04
go-dry US Vet Inc, GC Hanford Manufacturing Company, Sandoz GmbH	Animal Medication	2025-03-16
Denagard 80 coated Type A Medicated Article Elanco US Inc.	Animal Medication	2025-01-14
TAZICEF Hospira, Inc., Sandoz GmbH	Prescription Medication	2024-07-05
Amoxicillin and Clavulanate Potassium Bionpharma Inc., Sandoz GmbH	Prescription Medication	2024-05-14
TAZICEF Hospira, Inc., Sandoz GmbH	Prescription Medication	2024-05-08
Amoxicillin and Clavulanate Potassium Bionpharma Inc., Sandoz GmbH	Prescription Medication	2024-02-24
go-dry US Vet Inc, GC Hanford Manufacturing Company, Sandoz GmbH	Animal Medication	2024-02-08
Denagard 80 coated Type A Medicated Article Elanco US Inc.	Animal Medication	2023-10-05
Amoxicillin and Clavulanate Potassium Bionpharma Inc., Sandoz GmbH	Prescription Medication	2023-06-09
GUDID 47612799222856 Sandoz GmbH	Omnitrope Pen 10	2023-04-03
Denagard 80 coated Type A Medicated Article Elanco US Inc.	Animal Medication	2023-04-01
Denagard 80 coated Type A Medicated Article Elanco US Inc.	Animal Medication	2023-03-21
TAZICEF Hospira, Inc., Sandoz GmbH	Prescription Medication	2023-03-15
TAZICEF Hospira, Inc., Sandoz GmbH	Prescription Medication	2023-03-12
GUDID 49002269218553 Sandoz GmbH	Omnitrope Pen 10	2023-02-15
GUDID 47612799222849 Sandoz GmbH	Omnitrope Pen 5	2023-02-15
Denagard 80 coated Type A Medicated Article Elanco US Inc.	Animal Medication	2022-11-19
Denagard 80 coated Type A Medicated Article Elanco US Inc.	Animal Medication	2022-11-11
Amoxicillin and Clavulanate Potassium Bionpharma Inc., Sandoz GmbH	Prescription Medication	2022-11-08
Amoxicillin and Clavulanate Potassium Bionpharma Inc., Sandoz GmbH	Prescription Medication	2022-08-01
TAZICEF Hospira, Inc., Sandoz GmbH	Prescription Medication	2022-04-06
TAZICEF Hospira, Inc., Sandoz GmbH	Prescription Medication	2022-04-06
TAZICEF Hospira, Inc., Sandoz GmbH	Prescription Medication	2022-03-17
TAZICEF Hospira, Inc., Sandoz GmbH	Prescription Medication	2022-03-16
TAZICEF Hospira, Inc., Sandoz GmbH	Prescription Medication	2021-11-03
TAZICEF Hospira, Inc., Sandoz GmbH	Prescription Medication	2021-09-22
TAZICEF Hospira, Inc., Sandoz GmbH	Prescription Medication	2021-09-22
TAZICEF Hospira, Inc., Sandoz GmbH	Prescription Medication	2021-08-21
Ampicillin Fresenius Kabi USA, LLC, Sandoz GmbH	Prescription Medication	2021-03-24
TAZICEF Hospira, Inc., Sandoz GmbH	Prescription Medication	2021-03-02
TAZICEF Hospira, Inc., Sandoz GmbH	Prescription Medication	2021-03-02
TAZICEF Hospira, Inc., Sandoz GmbH	Prescription Medication	2021-03-02
TAZICEF Hospira, Inc., Sandoz GmbH	Prescription Medication	2021-02-27
TAZICEF Hospira, Inc., Sandoz GmbH	Prescription Medication	2021-02-27
TAZICEF Hospira, Inc., Sandoz GmbH	Prescription Medication	2021-02-27
go-dry US Vet Inc, GC Hanford Manufacturing Company, Sandoz GmbH	Animal Medication	2021-01-29
TAZICEF Hospira, Inc., Sandoz GmbH	Prescription Medication	2021-01-07
TAZICEF Hospira, Inc., Sandoz GmbH	Prescription Medication	2021-01-07
TAZICEF Hospira, Inc., Sandoz GmbH	Prescription Medication	2021-01-07
Nafcillin Hospira, Inc, Corden Pharma Latina S.p.A., Sandoz GmbH	Prescription Medication	2020-12-15
GUDID 57613421039603 Sandoz GmbH	Glatopaject® 49020084	2020-10-27
Ampicillin Fresenius Kabi USA, LLC, Sandoz GmbH	Prescription Medication	2020-07-15
Piperacillin and Tazobactam Sandoz GmbH	Prescription Medication	2020-07-09
Piperacillin and Tazobactam Sandoz GmbH	Prescription Medication	2020-06-30
Ampicillin and Sulbactam Sandoz GmbH	Prescription Medication	2020-06-26
Cefazolin Sandoz GmbH	Prescription Medication	2020-06-26
TAZICEF Hospira, Inc., Sandoz GmbH	Prescription Medication	2020-06-13
Piperacillin and Tazobactam Sandoz GmbH	Prescription Medication	2020-06-12
Ampicillin Fresenius Kabi USA, LLC, Sandoz GmbH	Prescription Medication	2020-01-23
Amoxicillin and Clavulanate Potassium Sandoz GmbH	Prescription Medication	2019-12-11
TAZICEF Hospira, Inc., Sandoz GmbH	Prescription Medication	2019-08-30
FISH PEN Thomas Labs, LLC, ANDAPharm, Sandoz GmbH, Aurobindo Pharma Limited	Animal Medication	2019-04-06
FISH PEN FORTE Thomas Labs, LLC, ANDAPharm, Sandoz GmbH, Aurobindo Pharma Limited	Animal Medication	2019-04-06
TAZICEF Hospira, Inc., Sandoz GmbH	Prescription Medication	2019-03-19
TAZICEF Hospira, Inc., Sandoz GmbH	Prescription Medication	2019-03-19
Piperacillin and Tazobactam Sandoz GmbH	Prescription Medication	2018-09-07
Ampicillin Fresenius Kabi USA, LLC, Sandoz GmbH	Prescription Medication	2018-07-13
Ceftriaxone Sodium Sandoz GmbH	Prescription Medication	2018-04-23
GUDID 59002269209466 Sandoz GmbH	Glatopaject® 49020084	2018-03-29
Ceftriaxone Sodium Sandoz GmbH	Prescription Medication	2018-03-17
Ceftriaxone Sodium Sandoz GmbH, Qilu Antibiotics Pharmaceutical Co., Ltd.	Prescription Medication	2018-03-15
Nafcillin Hospira, Inc, Corden Pharma Latina S.p.A., Sandoz GmbH	Prescription Medication	2017-09-30
Ampicillin Sandoz GmbH	Prescription Medication	2017-08-31
Ampicillin Sandoz GmbH	Prescription Medication	2017-08-31
Ampicillin Sandoz GmbH	Prescription Medication	2017-08-31
Nafcillin Sandoz GmbH	Prescription Medication	2017-08-09
Nafcillin Sandoz GmbH	Prescription Medication	2017-08-09
Denagard 80 coated Type A Medicated Article Elanco US Inc.	Animal Medication	2016-12-16
NDC 43858-153 Sandoz GmbH	Piperacillin And Tazobactam	2016-12-14
Keflex Shionogi Inc., DSM Sinochem Pharmaceuticals Spain S.A., Sandoz GmbH	Prescription Medication	2015-11-11
Amoxicillin and Clavulanate Potassium Sandoz GmbH	Prescription Medication	2015-10-29
NDC 43858-607 Sandoz GmbH	Amoxicillin And Clavulanate Potassium	2015-10-21
NDC 43858-606 Sandoz GmbH	Amoxicillin And Clavulanate Potassium	2015-10-21
NDC 43858-605 Sandoz GmbH	Amoxicillin And Clavulanate Potassium	2015-10-21
NDC 43858-604 Sandoz GmbH	Amoxicillin And Clavulanate Potassium	2015-10-21
NDC 43858-603 Sandoz GmbH	Amoxicillin And Clavulanate Potassium	2015-10-21
NDC 43858-602 Sandoz GmbH	Amoxicillin And Clavulanate Potassium	2015-10-21
NDC 43858-601 Sandoz GmbH	Amoxicillin And Clavulanate Potassium	2015-10-21
NDC 43858-712 Sandoz GmbH		2015-03-24
NDC 43858-450 Sandoz GmbH		2014-01-23
NDC 43858-400 Sandoz GmbH		2014-01-17
Atenolol RedPharm Drug Inc., Sandoz GmbH	Prescription Medication	2011-08-15
Atenolol RedPharm Drug Inc., Sandoz GmbH	Prescription Medication	2011-08-12
Indomethacin RedPharm Drug Inc., Sandoz GmbH	Prescription Medication	2011-07-27
Amoxicillin RedPharm Drug Inc., Sandoz GmbH	Prescription Medication	2011-07-26
Alprazolam RedPharm, Sandoz GmbH	Prescription Medication	2011-07-07
Alprazolam RedPharm Drug Inc., Sandoz GmbH	Prescription Medication	2011-07-07
NDC 43858-160 Sandoz GmbH	Piperacillin And Tazobactam	2010-10-21
NDC 43858-148 Sandoz GmbH	Piperacillin And Tazobactam	2010-10-21
NDC 43858-147 Sandoz GmbH	Piperacillin And Tazobactam	2010-10-21
NDC 43858-146 Sandoz GmbH	Piperacillin And Tazobactam	2010-10-21
NDC 43858-145 Sandoz GmbH	Piperacillin And Tazobactam	2010-10-21
NDC 43858-144 Sandoz GmbH	Piperacillin And Tazobactam	2010-10-21
NDC 43858-475 Sandoz GmbH		2010-05-03
NDC 43858-710 Sandoz GmbH		2010-04-12
NDC 43858-480 Sandoz GmbH		2010-02-12
NDC 43858-320 Sandoz GmbH		2010-02-09
NDC 43858-540 Sandoz GmbH		2010-02-01
NDC 43858-511 Sandoz GmbH		2010-02-01
NDC 43858-510 Sandoz GmbH		2010-02-01
NDC 43858-502 Sandoz GmbH		2010-02-01
NDC 43858-501 Sandoz GmbH		2010-02-01
NDC 43858-500 Sandoz GmbH		2010-02-01
NDC 43858-460 Sandoz GmbH		2010-02-01
NDC 43858-420 Sandoz GmbH		2010-02-01
NDC 43858-410 Sandoz GmbH		2010-02-01
NDC 43858-490 Sandoz GmbH		2010-01-19
NDC 43858-711 Sandoz GmbH		2008-04-22
NDC 43858-100 Sandoz GmbH	Cefazolin	2007-05-09
NDC 43858-134 Sandoz GmbH	Ampicillin And Sulbactam	2006-07-25
NDC 43858-133 Sandoz GmbH	Ampicillin And Sulbactam	2006-07-25
NDC 43858-635 Sandoz GmbH	Ceftriaxone Sodium	2005-05-17
NDC 43858-634 Sandoz GmbH	Ceftriaxone Sodium	2005-05-09
NDC 43858-633 Sandoz GmbH	Ceftriaxone Sodium	2005-05-09
NDC 43858-632 Sandoz GmbH	Ceftriaxone Sodium	2005-05-09
NDC 43858-631 Sandoz GmbH	Ceftriaxone Sodium	2005-05-09
NDC 43858-637 Sandoz GmbH	Ceftriaxone Sodium	2005-05-03
NDC 43858-636 Sandoz GmbH	Ceftriaxone Sodium	2005-05-03
NDC 43858-124 Sandoz GmbH	Ampicillin	1987-02-19
NDC 43858-123 Sandoz GmbH	Ampicillin	1987-02-19
NDC 43858-118 Sandoz GmbH	Nafcillin	1984-08-02
NDC 43858-117 Sandoz GmbH	Nafcillin	1984-08-02
NDC 43858-116 Sandoz GmbH	Nafcillin	1984-08-02
NDC 43858-115 Sandoz GmbH	Ampicillin	1971-03-03
NDC 43858-114 Sandoz GmbH	Ampicillin	1971-03-03
NDC 43858-113 Sandoz GmbH	Ampicillin	1971-03-03
NDC 43858-112 Sandoz GmbH	Ampicillin	1971-03-03
NDC 43858-111 Sandoz GmbH	Ampicillin	1971-03-03
NDC 43858-110 Sandoz GmbH	Ampicillin	1971-03-03

Similar & Related FDA Registered Companies

Related Finance Registrations

NCAGE Code	2253N	SANDOZ GMBH
NCAGE Code	5364N	SANDOZ GMBH
CAGE Code	2253N	SANDOZ GMBH
CAGE Code	5364N	SANDOZ GMBH

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092813423	Stadersand,Federal Republic of Germany -> Oakland, California	ORGANIC FERTILIZER	870 PKG
2020092277102	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	CLAVACILLIN DEC 250MG 210FCT ST US NDC 17033-442-21 CLAVACILLIN 125MG FILM-COATED-TABLETS IP/210 (14X15) SHIPPINGS MARKS:	16 PKG
2020092161314	Anvers,Belgium -> Philadelphia, Pennsylvania	40 PLTS PIPERACILLIN TAZOBACTAM 4,5G VIALS IP /10 (10X1)	16055 PCS
2020092161684	Anvers,Belgium -> Philadelphia, Pennsylvania	37 PLTS PIPERACILLIN TAZOBACTAM 4,5G VIALS IP /10 (10X1)	14988 PCS
2020092161750	Anvers,Belgium -> Philadelphia, Pennsylvania	11 PLTS PIPERACILLIN TAZOBACTAM 4,5G VIALS IP /10 (10X1)	15756 PCS
2020092161750	Anvers,Belgium -> Philadelphia, Pennsylvania	29 PLTS PIPERACILLIN TAZOBACTAM 4,5G VIALS IP /10 (10X1)	15756 PCS
2020092161494	Anvers,Belgium -> Philadelphia, Pennsylvania	4 PLTS AMPICILLIN FOR INJECTION, USP 2 GRAMS HP/10	75770 PCS
2020092161494	Anvers,Belgium -> Philadelphia, Pennsylvania	2 PLTS PIPERACILLIN TAZOBACTAM 3,375G VIALS I P/10 (10X1)	75770 PCS
2020092161494	Anvers,Belgium -> Philadelphia, Pennsylvania	5 PLTS AMOX CLAV POT 875/125MG 20.00	75770 PCS
2020092161494	Anvers,Belgium -> Philadelphia, Pennsylvania	19 PLTS CEFTRIAXONE INJ 10G PB/100ML VIAL	75770 PCS
2020092161494	Anvers,Belgium -> Philadelphia, Pennsylvania	7 PLTS AMPICILLIN FOR INJECTION, USP 1 G HP/1 0	75770 PCS
2020092161474	Anvers,Belgium -> Philadelphia, Pennsylvania	31 PALLETS AMOXICILLIN 500 MG 500 CAPSULES	23114 PCS
2020092161474	Anvers,Belgium -> Philadelphia, Pennsylvania	7 PLTS AMPICILLIN FOR INJECTION, USP 1 G HP/1 0	23114 PCS
2020092161723	Anvers,Belgium -> Philadelphia, Pennsylvania	13 PLTS PIPERACILLIN TAZOBACTAM 3,375G VIALS IP/10 (10X1)	21053 PCS
2020092161723	Anvers,Belgium -> Philadelphia, Pennsylvania	27 PLTS PIPERACILLIN TAZOBACTAM 4,5G VIALS IP /10 (10X1)	21053 PCS