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 Number3006532887
FEI Number3002809299
NameOTSUKA PHARMACEUTICAL CO., LTD. TOKUSHIMA FACTORY
Owner & OperatorOTSUKA PHARMACEUTICAL CO., LTD.
Contact AddressSHINAGAWA GRAND CENTRAL TOWER 2-16-4 KONAN, MINATO-KU
TOKYO JP-13 Tokyo 108-8242 JP
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address463-10 KAGASUNO, KAWAUCHI-CHO
TOKUSHIMA Tokusima, 771-0192 JP
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility



Registration Number3005622096
FEI Number3005622096
NameGordon MacFarlane
Owner & OperatorOTSUKA PHARMACEUTICAL CO., LTD.
Contact AddressSHINAGAWA GRAND CENTRAL TOWER 2-16-4 KONAN, MINATO-KU
TOKYO JP-13 Tokyo 108-8242 JP
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2100 Pennbrook Pkwy
North Wales, PA 19454 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Sharp Corporation, Eurofins Lancaster Laboratories, Boston Analytical Inc, Legacy Pharmaceutical Packaging, LLC
Prescription Medication2024-05-22
Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Sharp Corporation, Eurofins Lancaster Laboratories, Boston Analytical Inc, Legacy Pharmaceutical Packaging, LLC
Prescription Medication2023-05-23
Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Sharp Corporation, Eurofins Lancaster Laboratories, Boston Analytical Inc, Legacy Pharmaceutical Packaging, LLC
Prescription Medication2023-05-02
Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Sharp Corporation, Eurofins Lancaster Laboratories, Boston Analytical Inc, Legacy Pharmaceutical Packaging, LLC
Prescription Medication2023-02-24
Otsuka America Pharmaceutical, Inc., Sharp Packaging Services, LLC, Eurofins Lancaster Laboratories, Inc, Packaging Coordinators, LLC, Boston Analytical Inc, Otsuka Pharmaceutical Co Ltd
Prescription Medication2022-11-19
Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Sharp Corporation, Eurofins Lancaster Laboratories, Boston Analytical Inc, Legacy Pharmaceutical Packaging, LLC
Prescription Medication2022-11-19
Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Boston Analytical Inc, AndersonBrecon Inc, Eurofins Lancaster Laboratories, Inc, Sharp Corporation
Prescription Medication2022-11-16
Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Sharp Corporation, Eurofins Lancaster Laboratories, Boston Analytical Inc, Legacy Pharmaceutical Packaging, LLC
Prescription Medication2022-01-06
Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Sharp Corporation, Eurofins Lancaster Laboratories, Boston Analytical Inc, Legacy Pharmaceutical Packaging, LLC
Prescription Medication2021-08-13
Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Sharp Corporation, Eurofins Lancaster Laboratories, Boston Analytical Inc, Legacy Pharmaceutical Packaging, LLC
Prescription Medication2021-07-28
Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Boston Analytical Inc, AndersonBrecon Inc, Eurofins Lancaster Laboratories, Inc, Sharp Corporation
Prescription Medication2021-07-22
Otsuka America Pharmaceutical, Inc., Sharp Packaging Services, LLC, Eurofins Lancaster Laboratories, Inc, Packaging Coordinators, LLC, Boston Analytical Inc, Otsuka Pharmaceutical Co Ltd
Prescription Medication2021-06-22
Otsuka America Pharmaceutical, Inc., Sharp Packaging Services, LLC, Eurofins Lancaster Laboratories, Inc, Packaging Coordinators, LLC, Boston Analytical Inc, Otsuka Pharmaceutical Co Ltd
Prescription Medication2021-05-05
Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Sharp Corporation, Eurofins Lancaster Laboratories, Boston Analytical Inc, Legacy Pharmaceutical Packaging, LLC
Prescription Medication2021-02-23
Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Boston Analytical Inc, AndersonBrecon Inc, Eurofins Lancaster Laboratories, Inc, Sharp Corporation
Prescription Medication2021-02-13
Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Sharp Corporation, Eurofins Lancaster Laboratories, Boston Analytical Inc, Legacy Pharmaceutical Packaging, LLC
Prescription Medication2021-01-15
Otsuka America Pharmaceutical, Inc., Sharp Packaging Services, LLC, Eurofins Lancaster Laboratories, Inc, Packaging Coordinators, LLC, Boston Analytical Inc, Otsuka Pharmaceutical Co Ltd
Prescription Medication2020-10-31
OTSUKA PHARMACEUTICAL CO., LTD.
2020-07-07
Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Sharp Corporation, Eurofins Lancaster Laboratories, Boston Analytical Inc, Legacy Pharmaceutical Packaging, LLC
Prescription Medication2020-07-01
Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Sharp Corporation, Eurofins Lancaster Laboratories, Boston Analytical Inc, Legacy Pharmaceutical Packaging, LLC
Prescription Medication2020-04-04
Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Boston Analytical Inc, AndersonBrecon Inc, Eurofins Lancaster Laboratories, Inc, Sharp Corporation
Prescription Medication2020-04-01
Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Boston Analytical Inc, AndersonBrecon Inc, Eurofins Lancaster Laboratories, Inc, Sharp Corporation
Prescription Medication2020-01-31
Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Sharp Corporation, Eurofins Lancaster Laboratories, Boston Analytical Inc, Legacy Pharmaceutical Packaging, LLC
Prescription Medication2019-06-15
Otsuka America Pharmaceutical, Inc., Sharp Packaging Services, LLC, Eurofins Lancaster Laboratories, Inc, Packaging Coordinators, LLC, Boston Analytical Inc, Otsuka Pharmaceutical Co Ltd
Prescription Medication2019-05-29
Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Boston Analytical Inc, AndersonBrecon Inc, Eurofins Lancaster Laboratories, Inc, Sharp Corporation
Prescription Medication2019-03-06
OTSUKA PHARMACEUTICAL CO., LTD.
2016-04-25
OTSUKA PHARMACEUTICAL CO., LTD.
2016-04-25
OTSUKA PHARMACEUTICAL CO., LTD.
2016-04-25
OTSUKA PHARMACEUTICAL CO., LTD.
2016-04-25
OTSUKA PHARMACEUTICAL CO., LTD.
2016-04-25
OTSUKA PHARMACEUTICAL CO., LTD.
2016-04-25
OTSUKA PHARMACEUTICAL CO., LTD.
2015-07-11
OTSUKA PHARMACEUTICAL CO., LTD.
2015-07-11
OTSUKA PHARMACEUTICAL CO., LTD.
2015-07-11
OTSUKA PHARMACEUTICAL CO., LTD.
2015-07-11
OTSUKA PHARMACEUTICAL CO., LTD.
2015-07-11
OTSUKA PHARMACEUTICAL CO., LTD.
2015-07-11
OTSUKA PHARMACEUTICAL CO., LTD.
2014-10-01
OTSUKA PHARMACEUTICAL CO., LTD.
2014-10-01
OTSUKA PHARMACEUTICAL CO., LTD. TOKUSHIMA FACTORY [OTSUKA PHARMACEUTICAL CO., LTD.]
Tris-buffer for stabilizing2014-03-25
OTSUKA PHARMACEUTICAL CO., LTD.
2013-09-01
OTSUKA PHARMACEUTICAL CO., LTD.
2013-09-01
OTSUKA PHARMACEUTICAL CO., LTD.
2013-09-01
OTSUKA PHARMACEUTICAL CO., LTD.
2013-09-01
OTSUKA PHARMACEUTICAL CO., LTD.
2013-09-01
OTSUKA PHARMACEUTICAL CO., LTD. TOKUSHIMA FACTORY [OTSUKA PHARMACEUTICAL CO., LTD.]
Latex sensitized anti-adiponectin antibody2013-03-21
OTSUKA PHARMACEUTICAL CO., LTD.
2012-09-01
OTSUKA PHARMACEUTICAL CO., LTD.
2012-09-01
Gordon MacFarlane [OTSUKA PHARMACEUTICAL CO., LTD.]
POC-AS10 Auto sampler2010-03-14
Gordon MacFarlane [OTSUKA PHARMACEUTICAL CO., LTD.]
POC-AS10 Auto sampler2010-03-14
OTSUKA PHARMACEUTICAL CO., LTD.
POC-AS10 AUTO SAMPLER2010-03-09
Gordon MacFarlane [OTSUKA PHARMACEUTICAL CO., LTD.]
POCone Spectrophotometer2008-04-24
Gordon MacFarlane [OTSUKA PHARMACEUTICAL CO., LTD.]
POCone Spectrophotometer2008-04-24
Gordon MacFarlane [OTSUKA PHARMACEUTICAL CO., LTD.]
UBiT-IR300 Spectrophotometer2008-04-24
OTSUKA PHARMACEUTICAL CO., LTD.
RAPIRUN H. PYLORI ANTIBODY DETECTION KIT2006-11-16
OTSUKA PHARMACEUTICAL CO., LTD.
2006-01-01
OTSUKA PHARMACEUTICAL CO., LTD.
POCONE INFRARED SPECTROPHOTOMETER2004-07-15
OTSUKA PHARMACEUTICAL CO., LTD.
2003-01-01
OTSUKA PHARMACEUTICAL CO., LTD.
2002-12-01
OTSUKA PHARMACEUTICAL CO., LTD.
2002-12-01
OTSUKA PHARMACEUTICAL CO., LTD.
2002-12-01
OTSUKA PHARMACEUTICAL CO., LTD.
2002-12-01
OTSUKA PHARMACEUTICAL CO., LTD.
UBIT-IR300 INFRARED SPECTROMETRY SYSTEM2001-12-21
OTSUKA PHARMACEUTICAL CO., LTD.
RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY2000-07-24
OTSUKA PHARMACEUTICAL CO., LTD.
RLP CHOLESTEROL IMMUNOSEPARATION ASSAY1999-08-20

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Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2019113031344Pusan,South Korea -> New York/Newark Area, Newark, New JerseyMEDICAMENTS, IN MEASURED DOSES, RETAIL PACKI352 CTN
201911053055Pusan,South Korea -> New York/Newark Area, Newark, New JerseyMEDICAMENTS, IN MEASURED DOSES, RETAIL PACKI372 CTN
201911022870Pusan,South Korea -> New York/Newark Area, Newark, New JerseyMEDICAMENTS, IN MEASURED DOSES, RETAIL PACKI372 CTN
201910295610Pusan,South Korea -> New York/Newark Area, Newark, New JerseyMEDICAMENTS, IN MEASURED DOSES, RETAIL PACKI372 CTN
2019101221845Pusan,South Korea -> New York/Newark Area, Newark, New JerseyMEDICAMENTS, IN MEASURED DOSES, RETAIL PACKI356 CTN
2019081024253Pusan,South Korea -> New York/Newark Area, Newark, New JerseyMEDICAMENTS, IN MEASURED DOSES, RETAIL PACKI400 CTN
2019071323017Pusan,South Korea -> New York/Newark Area, Newark, New JerseyMEDICAMENTS, IN MEASURED DOSES, RETAIL PACKI396 CTN
2019062221670Pusan,South Korea -> New York/Newark Area, Newark, New JerseyMEDICAMENTS, IN MEASURED DOSES, RETAIL PACKI348 CTN

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