This page includes the latest FDA filings for Otsuka America Pharmaceutical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Registration Number | 3000718406 |
FEI Number | 3000718406 |
Name | OTSUKA AMERICA PHARMACEUTICAL, INC. |
Owner & Operator | OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALIZATION, INC |
Contact Address | 2440 RESEARCH BLVD. -- Rockville MD 20850 US |
Official Correspondent |
|
Registration Status | 1 |
Initial Importer | Y |
Registration Expiration | 2020-04-25 |
Registration Address | 2440 Research Blvd Rockville, MD 20850 US |
Establishment Type |
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Device Company | Device | Date |
---|---|---|
Otsuka America Pharmaceutical, Inc | Prescription Medication | 2025-01-31 |
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 |
Otsuka America Pharmaceutical, Inc. | Prescription Medication | 2024-12-07 |
Otsuka America Pharmaceutical, Inc | Prescription Medication | 2024-12-04 |
Otsuka America Pharmaceutical, Inc. | Prescription Medication | 2024-07-24 |
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. | Prescription Medication | 2024-04-12 |
Otsuka America Pharmaceutical, Inc. | Prescription Medication | 2024-02-14 |
Otsuka America Pharmaceutical, Inc | Prescription Medication | 2024-02-01 |
Otsuka America Pharmaceutical, Inc. | Prescription Medication | 2023-12-16 |
Otsuka America Pharmaceutical, Inc. | Prescription Medication | 2023-12-07 |
Otsuka America Pharmaceutical, Inc. | Prescription Medication | 2023-10-17 |
Otsuka America Pharmaceutical, Inc | Prescription Medication | 2023-10-14 |
Otsuka America Pharmaceutical, Inc | Prescription Medication | 2023-08-29 |
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 | Prescription Medication | 2023-05-09 |
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. | Prescription Medication | 2023-03-02 |
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. | Prescription Medication | 2023-02-23 |
Otsuka America Pharmaceutical, Inc | Prescription Medication | 2023-01-05 |
Otsuka America Pharmaceutical, Inc | Nuedexta | 2023-01-03 |
Otsuka America Pharmaceutical, Inc. | Prescription Medication | 2022-12-14 |
Otsuka America Pharmaceutical, Inc. | Prescription Medication | 2022-12-14 |
Otsuka America Pharmaceutical, Inc. | Prescription Medication | 2022-12-06 |
Otsuka America Pharmaceutical, Inc. | Prescription Medication | 2022-11-23 |
Otsuka America Pharmaceutical, Inc. | Prescription Medication | 2022-11-22 |
Otsuka America Pharmaceutical, Inc., Sharp Packaging Services, LLC, Eurofins Lancaster Laboratories, Inc, Packaging Coordinators, LLC, Boston Analytical Inc, Otsuka Pharmaceutical Co Ltd | Prescription Medication | 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 Packaging Services, LLC | 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. | Prescription Medication | 2021-12-02 |
Otsuka America Pharmaceutical, Inc. | Prescription Medication | 2021-11-17 |
Otsuka America Pharmaceutical, Inc. | Prescription Medication | 2021-09-24 |
Otsuka America Pharmaceutical, Inc. | Prescription Medication | 2021-09-18 |
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. | Prescription Medication | 2021-08-05 |
Otsuka America Pharmaceutical, Inc. | Prescription Medication | 2021-08-03 |
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 Packaging Services, LLC | 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. | Prescription Medication | 2021-05-19 |
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 | MyCite Patch | 2021-04-22 |
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 Packaging Services, LLC | Prescription Medication | 2021-02-13 |
Otsuka America Pharmaceutical Inc | MyCite Patch | 2021-01-18 |
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 America Pharmaceutical, Inc. | Prescription Medication | 2020-07-16 |
Otsuka America Pharmaceutical, Inc. | Prescription Medication | 2020-07-15 |
Otsuka America Pharmaceutical, Inc. | Prescription Medication | 2020-07-02 |
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. | Prescription Medication | 2020-06-17 |
Otsuka America Pharmaceutical, Inc. | Prescription Medication | 2020-06-17 |
OTSUKA AMERICA PHARMACEUTICAL, INC. | BreathTek UBT for H. pylori Kit and Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA) | 2020-05-26 |
Otsuka America Pharmaceutical, Inc., Galbraith Laboratories, Inc., Eurofins Lancaster Laboratories, Inc, Avista Pharma Solutions, Inc., Alcami Missouri Corporation, Sharp Corporation, Baxter Oncology GmbH, Mayne Pharma Inc. | Prescription Medication | 2020-04-28 |
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 Packaging Services, LLC | Prescription Medication | 2020-04-01 |
Otsuka America Pharmaceutical, Inc. | Prescription Medication | 2020-03-31 |
Otsuka America Pharmaceutical, Inc. | Prescription Medication | 2020-03-27 |
Otsuka America Pharmaceutical, Inc. | Prescription Medication | 2020-03-07 |
Otsuka America Pharmaceutical, Inc. | Prescription Medication | 2020-02-15 |
Otsuka America Pharmaceutical, Inc. | Prescription Medication | 2020-02-15 |
Otsuka America Pharmaceutical, Inc. | Prescription Medication | 2020-02-15 |
Otsuka America Pharmaceutical, Inc. | Jynarque | 2020-01-31 |
Otsuka America Pharmaceutical, Inc. | Jynarque | 2020-01-31 |
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 |
Otsuka America Pharmaceutical, Inc. | Prescription Medication | 2019-08-22 |
Otsuka America Pharmaceutical, Inc., Galbraith Laboratories, Inc., Eurofins Lancaster Laboratories, Inc, Avista Pharma Solutions, Inc., Alcami Missouri Corporation, Sharp Corporation, Baxter Oncology GmbH, Mayne Pharma Inc. | Prescription Medication | 2019-07-31 |
Otsuka America Pharmaceutical, Inc. | Prescription Medication | 2019-07-25 |
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. | Prescription Medication | 2019-04-13 |
Otsuka America Pharmaceutical, Inc. | Prescription Medication | 2019-03-30 |
Otsuka America Pharmaceutical, Inc. | Prescription Medication | 2019-03-08 |
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 |
Otsuka America Pharmaceutical Inc | Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA | 2018-07-06 |
Otsuka America Pharmaceutical Inc | Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA | 2018-07-06 |
Otsuka America Pharmaceutical Inc | BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) | 2018-07-06 |
OTSUKA AMERICA PHARMACEUTICAL, INC. | BreathTek UBT for H.pylori Kit (BreathTek UBT Kit), Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA) | 2018-06-05 |
Otsuka America Pharmaceutical, Inc. | Jynarque | 2018-04-23 |
Otsuka America Pharmaceutical, Inc. | Jynarque | 2018-04-23 |
Otsuka America Pharmaceutical, Inc. | Jynarque | 2018-04-23 |
Otsuka America Pharmaceutical, Inc. | JYNARQUE | 2018-04-23 |
Otsuka America Pharmaceutical, Inc. | JYNARQUE | 2018-04-23 |
Otsuka America Pharmaceutical Inc | BreathTek® UBT for H. pylori Kit (Metabolic Solutions Kit) | 2018-03-29 |
Otsuka America Pharmaceutical, Inc. | Abilify MyCite | 2018-01-31 |
Otsuka America Pharmaceutical, Inc. | Abilify MyCite | 2018-01-31 |
Otsuka America Pharmaceutical, Inc. | Abilify MyCite | 2018-01-31 |
Otsuka America Pharmaceutical, Inc. | Abilify MyCite | 2018-01-31 |
Otsuka America Pharmaceutical, Inc. | Abilify MyCite | 2018-01-31 |
Otsuka America Pharmaceutical, Inc. | Abilify MyCite | 2018-01-31 |
OTSUKA AMERICA PHARMACEUTICAL, INC. | BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0 | 2017-03-30 |
OTSUKA AMERICA PHARMACEUTICAL, INC. | BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0 | 2017-01-04 |
OTSUKA AMERICA PHARMACEUTICAL, INC. | BREATH TEK UBT FOR H.PYLORI KIT (BREATH TEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA | 2016-01-27 |
OTSUKA AMERICA PHARMACEUTICAL, INC. | BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA) | 2015-11-23 |
Otsuka America Pharmaceutical, Inc. | REXULTI | 2015-07-10 |
Otsuka America Pharmaceutical, Inc. | REXULTI | 2015-07-10 |
Otsuka America Pharmaceutical, Inc. | REXULTI | 2015-07-10 |
Otsuka America Pharmaceutical, Inc. | REXULTI | 2015-07-10 |
Otsuka America Pharmaceutical, Inc. | REXULTI | 2015-07-10 |
Otsuka America Pharmaceutical, Inc. | REXULTI | 2015-07-10 |
OTSUKA AMERICA PHARMACEUTICAL, INC. | BREATHTEK UBT FOR H.PYLORI KIT | 2015-03-05 |
Otsuka America Pharmaceutical, Inc. | BUSULFEX | 2015-02-13 |
OTSUKA AMERICA PHARMACEUTICAL, INC. | BREATH TEK UBT FOR H PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PHUR-CA) | 2015-02-03 |
Otsuka America Pharmaceutical, Inc. | ABILIFY MAINTENA | 2014-10-08 |
Otsuka America Pharmaceutical, Inc. | ABILIFY MAINTENA | 2014-10-08 |
OTSUKA AMERICA PHARMACEUTICAL, INC. | BREATHTEK UBT FOR H.PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA) | 2014-04-18 |
OTSUKA AMERICA PHARMACEUTICAL, INC. | BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA) | 2014-02-19 |
OTSUKA AMERICA PHARMACEUTICAL, INC. | BREATH TEK UBT FOR H. PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR | 2013-05-29 |
OTSUKA AMERICA PHARMACEUTICAL, INC. | BREATH TEK UBT FOR H PYLORI KIT (BREATH TEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION(PUHR-CA) | 2013-05-23 |
Otsuka America Pharmaceutical, Inc. | ABILIFY MAINTENA | 2013-02-28 |
Otsuka America Pharmaceutical, Inc. | ABILIFY MAINTENA | 2013-02-28 |
OTSUKA AMERICA PHARMACEUTICAL, INC. [OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALIZATION, INC] | BreathTek UBT for H.pylori and pediatric urea hydrolysis rate calculation application (pUHR-CA) | 2012-11-28 |
OTSUKA AMERICA PHARMACEUTICAL, INC. | BREATHTEK UBT FOR H. PYLORI HIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE APPLICATION (PUHR-CA) | 2012-11-06 |
OTSUKA AMERICA PHARMACEUTICAL, INC. | BREATH TEK UBTFOR H. PYLORI KIT | 2012-09-05 |
OTSUKA AMERICA PHARMACEUTICAL, INC. | BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0 | 2012-02-22 |
H.J. Harkins Company, Inc., Otsuka America Pharmaceutical, Inc., Perrigo Nwe York Inc | Prescription Medication | 2011-12-05 |
Otsuka America Pharmaceutical, Inc. | SAMSCA | 2009-05-19 |
Otsuka America Pharmaceutical, Inc. | SAMSCA | 2009-05-19 |
OTSUKA AMERICA PHARMACEUTICAL, INC. [OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALIZATION, INC] | BREATHTEK UBT FOR | 2007-09-13 |
Otsuka America Pharmaceutical, Inc. | ABILIFY | 2006-09-20 |
Otsuka America Pharmaceutical, Inc. | ABILIFY | 2006-06-07 |
Otsuka America Pharmaceutical, Inc. | ABILIFY | 2006-06-07 |
Otsuka America Pharmaceutical, Inc. | Dacogen | 2006-05-02 |
Otsuka America Pharmaceutical, Inc. | ABILIFY | 2004-12-10 |
Otsuka America Pharmaceutical, Inc. | ABILIFY | 2002-11-15 |
Otsuka America Pharmaceutical, Inc. | ABILIFY | 2002-11-15 |
Otsuka America Pharmaceutical, Inc. | ABILIFY | 2002-11-15 |
Otsuka America Pharmaceutical, Inc. | ABILIFY | 2002-11-15 |
Otsuka America Pharmaceutical, Inc. | ABILIFY | 2002-11-15 |
Otsuka America Pharmaceutical, Inc. | ABILIFY | 2002-11-15 |
Otsuka America Pharmaceutical, Inc. | BUSULFEX | 1999-02-04 |
NCAGE Code | 0ZHV7 | OTSUKA AMERICA PHARMACEUTICAL, INC. |
CAGE Code | 0ZHV7 | OTSUKA AMERICA PHARMACEUTICAL, INC. |
S.A.M. Registration | 0ZHV7 [8314390] | OTSUKA AMERICA PHARMACEUTICAL, INC. |
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 |