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.
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 |
|
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 |
|
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 |
Device Company | Device | Date |
---|---|---|
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 |
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 |
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 |
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 |
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 |
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 |
Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Boston Analytical Inc, AndersonBrecon Inc, Eurofins Lancaster Laboratories, Inc, Sharp Corporation | Prescription Medication | 2022-11-16 |
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 |
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 |
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 |
Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Boston Analytical Inc, AndersonBrecon Inc, Eurofins Lancaster Laboratories, Inc, Sharp Corporation | Prescription Medication | 2021-07-22 |
Otsuka America Pharmaceutical, Inc., Sharp Packaging Services, LLC, Eurofins Lancaster Laboratories, Inc, Packaging Coordinators, LLC, Boston Analytical Inc, Otsuka Pharmaceutical Co Ltd | Prescription Medication | 2021-06-22 |
Otsuka America Pharmaceutical, Inc., Sharp Packaging Services, LLC, Eurofins Lancaster Laboratories, Inc, Packaging Coordinators, LLC, Boston Analytical Inc, Otsuka Pharmaceutical Co Ltd | Prescription Medication | 2021-05-05 |
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 |
Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Boston Analytical Inc, AndersonBrecon Inc, Eurofins Lancaster Laboratories, Inc, Sharp Corporation | Prescription Medication | 2021-02-13 |
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 |
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 |
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 Medication | 2020-07-01 |
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 |
Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Boston Analytical Inc, AndersonBrecon Inc, Eurofins Lancaster Laboratories, Inc, Sharp Corporation | Prescription Medication | 2020-04-01 |
Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Boston Analytical Inc, AndersonBrecon Inc, Eurofins Lancaster Laboratories, Inc, Sharp Corporation | Prescription Medication | 2020-01-31 |
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 |
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 |
Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Boston Analytical Inc, AndersonBrecon Inc, Eurofins Lancaster Laboratories, Inc, Sharp Corporation | Prescription Medication | 2019-03-06 |
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 stabilizing | 2014-03-25 |
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 antibody | 2013-03-21 |
OTSUKA PHARMACEUTICAL CO., LTD. | 2012-09-01 | |
OTSUKA PHARMACEUTICAL CO., LTD. | 2012-09-01 | |
Gordon MacFarlane [OTSUKA PHARMACEUTICAL CO., LTD.] | POC-AS10 Auto sampler | 2010-03-14 |
Gordon MacFarlane [OTSUKA PHARMACEUTICAL CO., LTD.] | POC-AS10 Auto sampler | 2010-03-14 |
OTSUKA PHARMACEUTICAL CO., LTD. | POC-AS10 AUTO SAMPLER | 2010-03-09 |
Gordon MacFarlane [OTSUKA PHARMACEUTICAL CO., LTD.] | POCone Spectrophotometer | 2008-04-24 |
Gordon MacFarlane [OTSUKA PHARMACEUTICAL CO., LTD.] | POCone Spectrophotometer | 2008-04-24 |
Gordon MacFarlane [OTSUKA PHARMACEUTICAL CO., LTD.] | UBiT-IR300 Spectrophotometer | 2008-04-24 |
OTSUKA PHARMACEUTICAL CO., LTD. | RAPIRUN H. PYLORI ANTIBODY DETECTION KIT | 2006-11-16 |
OTSUKA PHARMACEUTICAL CO., LTD. | 2006-01-01 | |
OTSUKA PHARMACEUTICAL CO., LTD. | POCONE INFRARED SPECTROPHOTOMETER | 2004-07-15 |
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 SYSTEM | 2001-12-21 |
OTSUKA PHARMACEUTICAL CO., LTD. | RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY | 2000-07-24 |
OTSUKA PHARMACEUTICAL CO., LTD. | RLP CHOLESTEROL IMMUNOSEPARATION ASSAY | 1999-08-20 |
NCAGE Code | SP267 | OTSUKA PHARMACEUTICAL CO. LTD |
CAGE Code | SP267 | OTSUKA PHARMACEUTICAL CO. LTD |
SEC | 0001034230 | OTSUKA PHARMACEUTICAL CO LTD |
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 |