Otsuka Pharmaceutical Co L T D

FDA Filings

This page includes the latest FDA filings for Otsuka Pharmaceutical Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

Registration Number	3006532887
FEI Number	3002809299
Name	OTSUKA PHARMACEUTICAL CO., LTD. TOKUSHIMA FACTORY
Owner & Operator	OTSUKA PHARMACEUTICAL CO., LTD.
Contact Address	SHINAGAWA GRAND CENTRAL TOWER 2-16-4 KONAN, MINATO-KU TOKYO JP-13 Tokyo 108-8242 JP
US Agent	Gordon MacFarlane ICONplc 919 8738962 215 6996288 Gordon.MacFarlane@iconplc.com
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	463-10 KAGASUNO, KAWAUCHI-CHO TOKUSHIMA Tokusima, 771-0192 JP
Establishment Type	Develop Specifications But Do Not Manufacture At This Facility

Registration Number	3005622096
FEI Number	3005622096
Name	Gordon MacFarlane
Owner & Operator	OTSUKA PHARMACEUTICAL CO., LTD.
Contact Address	SHINAGAWA GRAND CENTRAL TOWER 2-16-4 KONAN, MINATO-KU TOKYO JP-13 Tokyo 108-8242 JP
US Agent	Gordon MacFarlane ICONplc 919 8738962 215 6996288 Gordon.MacFarlane@iconplc.com
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	2100 Pennbrook Pkwy North Wales, PA 19454 US
Establishment Type	Manufacture Medical Device

FDA Filings

Device Company	Device	Date
Rexulti Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Sharp Corporation, Eurofins Lancaster Laboratories, Boston Analytical Inc, Legacy Pharmaceutical Packaging, LLC	Prescription Medication	2025-06-22
Rexulti Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Sharp Corporation, Eurofins Lancaster Laboratories, Boston Analytical Inc, Legacy Pharmaceutical Packaging, LLC	Prescription Medication	2025-05-19
JYNARQUE Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Boston Analytical Inc, AndersonBrecon Inc, Eurofins Lancaster Laboratories, Inc, Sharp Packaging Services, LLC	Prescription Medication	2025-05-08
Rexulti Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Sharp Corporation, Eurofins Lancaster Laboratories, Boston Analytical Inc, Legacy Pharmaceutical Packaging, LLC	Prescription Medication	2025-02-07
JYNARQUE Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Boston Analytical Inc, AndersonBrecon Inc, Eurofins Lancaster Laboratories, Inc, Sharp Packaging Services, LLC	Prescription Medication	2025-01-19
Rexulti Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Sharp Corporation, Eurofins Lancaster Laboratories, Boston Analytical Inc, Legacy Pharmaceutical Packaging, LLC	Prescription Medication	2024-05-22
Rexulti Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Sharp Corporation, Eurofins Lancaster Laboratories, Boston Analytical Inc, Legacy Pharmaceutical Packaging, LLC	Prescription Medication	2023-05-23
Rexulti Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Sharp Corporation, Eurofins Lancaster Laboratories, Boston Analytical Inc, Legacy Pharmaceutical Packaging, LLC	Prescription Medication	2023-05-02
Rexulti Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Sharp Corporation, Eurofins Lancaster Laboratories, Boston Analytical Inc, Legacy Pharmaceutical Packaging, LLC	Prescription Medication	2023-02-24
SAMSCA Otsuka America Pharmaceutical, Inc., Sharp Packaging Services, LLC, Eurofins Lancaster Laboratories, Inc, Packaging Coordinators, LLC, Boston Analytical Inc, Otsuka Pharmaceutical Co Ltd	Prescription Medication	2022-11-19
Rexulti Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Sharp Corporation, Eurofins Lancaster Laboratories, Boston Analytical Inc, Legacy Pharmaceutical Packaging, LLC	Prescription Medication	2022-11-19
JYNARQUE Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Boston Analytical Inc, AndersonBrecon Inc, Eurofins Lancaster Laboratories, Inc, Sharp Packaging Services, LLC	Prescription Medication	2022-11-16
Rexulti Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Sharp Corporation, Eurofins Lancaster Laboratories, Boston Analytical Inc, Legacy Pharmaceutical Packaging, LLC	Prescription Medication	2022-01-06
Rexulti Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Sharp Corporation, Eurofins Lancaster Laboratories, Boston Analytical Inc, Legacy Pharmaceutical Packaging, LLC	Prescription Medication	2021-08-13
Rexulti Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Sharp Corporation, Eurofins Lancaster Laboratories, Boston Analytical Inc, Legacy Pharmaceutical Packaging, LLC	Prescription Medication	2021-07-28
JYNARQUE Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Boston Analytical Inc, AndersonBrecon Inc, Eurofins Lancaster Laboratories, Inc, Sharp Packaging Services, LLC	Prescription Medication	2021-07-22
SAMSCA Otsuka America Pharmaceutical, Inc., Sharp Packaging Services, LLC, Eurofins Lancaster Laboratories, Inc, Packaging Coordinators, LLC, Boston Analytical Inc, Otsuka Pharmaceutical Co Ltd	Prescription Medication	2021-06-22
SAMSCA Otsuka America Pharmaceutical, Inc., Sharp Packaging Services, LLC, Eurofins Lancaster Laboratories, Inc, Packaging Coordinators, LLC, Boston Analytical Inc, Otsuka Pharmaceutical Co Ltd	Prescription Medication	2021-05-05
Rexulti Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Sharp Corporation, Eurofins Lancaster Laboratories, Boston Analytical Inc, Legacy Pharmaceutical Packaging, LLC	Prescription Medication	2021-02-23
JYNARQUE Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Boston Analytical Inc, AndersonBrecon Inc, Eurofins Lancaster Laboratories, Inc, Sharp Packaging Services, LLC	Prescription Medication	2021-02-13
Rexulti Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Sharp Corporation, Eurofins Lancaster Laboratories, Boston Analytical Inc, Legacy Pharmaceutical Packaging, LLC	Prescription Medication	2021-01-15
SAMSCA Otsuka America Pharmaceutical, Inc., Sharp Packaging Services, LLC, Eurofins Lancaster Laboratories, Inc, Packaging Coordinators, LLC, Boston Analytical Inc, Otsuka Pharmaceutical Co Ltd	Prescription Medication	2020-10-31
NDC 46602-0112 OTSUKA PHARMACEUTICAL CO., LTD.		2020-07-07
Rexulti Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Sharp Corporation, Eurofins Lancaster Laboratories, Boston Analytical Inc, Legacy Pharmaceutical Packaging, LLC	Prescription Medication	2020-07-01
Rexulti Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Sharp Corporation, Eurofins Lancaster Laboratories, Boston Analytical Inc, Legacy Pharmaceutical Packaging, LLC	Prescription Medication	2020-04-04
JYNARQUE Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Boston Analytical Inc, AndersonBrecon Inc, Eurofins Lancaster Laboratories, Inc, Sharp Packaging Services, LLC	Prescription Medication	2020-04-01
JYNARQUE Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Boston Analytical Inc, AndersonBrecon Inc, Eurofins Lancaster Laboratories, Inc, Sharp Packaging Services, LLC	Prescription Medication	2020-01-31
Rexulti Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Sharp Corporation, Eurofins Lancaster Laboratories, Boston Analytical Inc, Legacy Pharmaceutical Packaging, LLC	Prescription Medication	2019-06-15
SAMSCA Otsuka America Pharmaceutical, Inc., Sharp Packaging Services, LLC, Eurofins Lancaster Laboratories, Inc, Packaging Coordinators, LLC, Boston Analytical Inc, Otsuka Pharmaceutical Co Ltd	Prescription Medication	2019-05-29
JYNARQUE Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Boston Analytical Inc, AndersonBrecon Inc, Eurofins Lancaster Laboratories, Inc, Sharp Packaging Services, LLC	Prescription Medication	2019-03-06
NDC 46602-1034 OTSUKA PHARMACEUTICAL CO., LTD.		2016-04-25
NDC 46602-1033 OTSUKA PHARMACEUTICAL CO., LTD.		2016-04-25
NDC 46602-1032 OTSUKA PHARMACEUTICAL CO., LTD.		2016-04-25
NDC 46602-1031 OTSUKA PHARMACEUTICAL CO., LTD.		2016-04-25
NDC 46602-1030 OTSUKA PHARMACEUTICAL CO., LTD.		2016-04-25
NDC 46602-1029 OTSUKA PHARMACEUTICAL CO., LTD.		2016-04-25
NDC 46602-0040 OTSUKA PHARMACEUTICAL CO., LTD.		2015-07-11
NDC 46602-0039 OTSUKA PHARMACEUTICAL CO., LTD.		2015-07-11
NDC 46602-0038 OTSUKA PHARMACEUTICAL CO., LTD.		2015-07-11
NDC 46602-0037 OTSUKA PHARMACEUTICAL CO., LTD.		2015-07-11
NDC 46602-0036 OTSUKA PHARMACEUTICAL CO., LTD.		2015-07-11
NDC 46602-0035 OTSUKA PHARMACEUTICAL CO., LTD.		2015-07-11
NDC 46602-0072 OTSUKA PHARMACEUTICAL CO., LTD.		2014-10-01
NDC 46602-0045 OTSUKA PHARMACEUTICAL CO., LTD.		2014-10-01
PPM OTSUKA PHARMACEUTICAL CO., LTD. TOKUSHIMA FACTORY [OTSUKA PHARMACEUTICAL CO., LTD.]	Tris-buffer for stabilizing	2014-03-25
NDC 46602-0031 OTSUKA PHARMACEUTICAL CO., LTD.		2013-09-01
NDC 46602-0030 OTSUKA PHARMACEUTICAL CO., LTD.		2013-09-01
NDC 46602-0029 OTSUKA PHARMACEUTICAL CO., LTD.		2013-09-01
NDC 46602-0028 OTSUKA PHARMACEUTICAL CO., LTD.		2013-09-01
NDC 46602-0027 OTSUKA PHARMACEUTICAL CO., LTD.		2013-09-01
MVU OTSUKA PHARMACEUTICAL CO., LTD. TOKUSHIMA FACTORY [OTSUKA PHARMACEUTICAL CO., LTD.]	Latex sensitized anti-adiponectin antibody	2013-03-21
NDC 46602-0026 OTSUKA PHARMACEUTICAL CO., LTD.		2012-09-01
NDC 46602-0025 OTSUKA PHARMACEUTICAL CO., LTD.		2012-09-01
PMN K092817 \| MSQ Gordon MacFarlane [OTSUKA PHARMACEUTICAL CO., LTD.]	POC-AS10 Auto sampler	2010-03-14
PMN K092817 \| JJQ Gordon MacFarlane [OTSUKA PHARMACEUTICAL CO., LTD.]	POC-AS10 Auto sampler	2010-03-14
PMN K092817 OTSUKA PHARMACEUTICAL CO., LTD.	POC-AS10 AUTO SAMPLER	2010-03-09
PMN K041148 \| MSQ Gordon MacFarlane [OTSUKA PHARMACEUTICAL CO., LTD.]	POCone Spectrophotometer	2008-04-24
PMN K041148 \| JJQ Gordon MacFarlane [OTSUKA PHARMACEUTICAL CO., LTD.]	POCone Spectrophotometer	2008-04-24
PMN K013371 \| JJQ Gordon MacFarlane [OTSUKA PHARMACEUTICAL CO., LTD.]	UBiT-IR300 Spectrophotometer	2008-04-24
PMN K052716 OTSUKA PHARMACEUTICAL CO., LTD.	RAPIRUN H. PYLORI ANTIBODY DETECTION KIT	2006-11-16
NDC 46602-0006 OTSUKA PHARMACEUTICAL CO., LTD.		2006-01-01
PMN K041148 OTSUKA PHARMACEUTICAL CO., LTD.	POCONE INFRARED SPECTROPHOTOMETER	2004-07-15
NDC 46602-0007 OTSUKA PHARMACEUTICAL CO., LTD.		2003-01-01
NDC 46602-0011 OTSUKA PHARMACEUTICAL CO., LTD.		2002-12-01
NDC 46602-0010 OTSUKA PHARMACEUTICAL CO., LTD.		2002-12-01
NDC 46602-0009 OTSUKA PHARMACEUTICAL CO., LTD.		2002-12-01
NDC 46602-0008 OTSUKA PHARMACEUTICAL CO., LTD.		2002-12-01
PMN K013371 OTSUKA PHARMACEUTICAL CO., LTD.	UBIT-IR300 INFRARED SPECTROMETRY SYSTEM	2001-12-21
PMN K001032 OTSUKA PHARMACEUTICAL CO., LTD.	RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY	2000-07-24
PMN K991083 OTSUKA PHARMACEUTICAL CO., LTD.	RLP CHOLESTEROL IMMUNOSEPARATION ASSAY	1999-08-20

Similar & Related FDA Registered Companies

Related Finance Registrations

NCAGE Code	SP267	OTSUKA PHARMACEUTICAL CO. LTD
CAGE Code	SP267	OTSUKA PHARMACEUTICAL CO. LTD
SEC	0001034230	OTSUKA PHARMACEUTICAL CO LTD

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2019113031344	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	MEDICAMENTS, IN MEASURED DOSES, RETAIL PACKI	352 CTN
201911053055	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	MEDICAMENTS, IN MEASURED DOSES, RETAIL PACKI	372 CTN
201911022870	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	MEDICAMENTS, IN MEASURED DOSES, RETAIL PACKI	372 CTN
201910295610	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	MEDICAMENTS, IN MEASURED DOSES, RETAIL PACKI	372 CTN
2019101221845	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	MEDICAMENTS, IN MEASURED DOSES, RETAIL PACKI	356 CTN
2019081024253	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	MEDICAMENTS, IN MEASURED DOSES, RETAIL PACKI	400 CTN
2019071323017	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	MEDICAMENTS, IN MEASURED DOSES, RETAIL PACKI	396 CTN
2019062221670	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	MEDICAMENTS, IN MEASURED DOSES, RETAIL PACKI	348 CTN