Otsuka America Pharmaceutical Inc

FDA Filings

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.

FDA Registration(s)
Registration Number3000718406
FEI Number3000718406
NameOTSUKA AMERICA PHARMACEUTICAL, INC.
Owner & OperatorOTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALIZATION, INC
Contact Address2440 RESEARCH BLVD. --
Rockville MD 20850 US
Official Correspondent
  • Michael Fahmy
  • x-609-5359659-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address2440 Research Blvd
Rockville, MD 20850 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Complaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Otsuka America Pharmaceutical, Inc.
Prescription Medication2024-02-14
Otsuka America Pharmaceutical, Inc
Prescription Medication2024-02-01
Otsuka America Pharmaceutical, Inc.
Prescription Medication2023-12-16
Otsuka America Pharmaceutical, Inc.
Prescription Medication2023-12-07
Otsuka America Pharmaceutical, Inc.
Prescription Medication2023-10-17
Otsuka America Pharmaceutical, Inc
Prescription Medication2023-10-14
Otsuka America Pharmaceutical, Inc
Prescription Medication2023-08-29
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
Prescription Medication2023-05-09
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.
Prescription Medication2023-03-02
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.
Prescription Medication2023-02-23
Otsuka America Pharmaceutical, Inc
Prescription Medication2023-01-05
Otsuka America Pharmaceutical, Inc
Nuedexta2023-01-03
Otsuka America Pharmaceutical, Inc.
Prescription Medication2022-12-14
Otsuka America Pharmaceutical, Inc.
Prescription Medication2022-12-14
Otsuka America Pharmaceutical, Inc.
Prescription Medication2022-12-06
Otsuka America Pharmaceutical, Inc.
Prescription Medication2022-11-23
Otsuka America Pharmaceutical, Inc.
Prescription Medication2022-11-22
Otsuka America Pharmaceutical, Inc., Sharp Packaging Services, LLC, Eurofins Lancaster Laboratories, Inc, Packaging Coordinators, LLC, Boston Analytical Inc, Otsuka Pharmaceutical Co Ltd
Prescription 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.
Prescription Medication2021-12-02
Otsuka America Pharmaceutical, Inc.
Prescription Medication2021-11-17
Otsuka America Pharmaceutical, Inc.
Prescription Medication2021-09-24
Otsuka America Pharmaceutical, Inc.
Prescription Medication2021-09-18
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.
Prescription Medication2021-08-05
Otsuka America Pharmaceutical, Inc.
Prescription Medication2021-08-03
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.
Prescription Medication2021-05-19
Otsuka America Pharmaceutical, Inc., Sharp Packaging Services, LLC, Eurofins Lancaster Laboratories, Inc, Packaging Coordinators, LLC, Boston Analytical Inc, Otsuka Pharmaceutical Co Ltd
Prescription Medication2021-05-05
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 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
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 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 America Pharmaceutical, Inc.
Prescription Medication2020-07-16
Otsuka America Pharmaceutical, Inc.
Prescription Medication2020-07-15
Otsuka America Pharmaceutical, Inc.
Prescription Medication2020-07-02
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.
Prescription Medication2020-06-17
Otsuka America Pharmaceutical, Inc.
Prescription Medication2020-06-17
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 Medication2020-04-28
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.
Prescription Medication2020-03-31
Otsuka America Pharmaceutical, Inc.
Prescription Medication2020-03-27
Otsuka America Pharmaceutical, Inc.
Prescription Medication2020-03-07
Otsuka America Pharmaceutical, Inc.
Prescription Medication2020-02-15
Otsuka America Pharmaceutical, Inc.
Prescription Medication2020-02-15
Otsuka America Pharmaceutical, Inc.
Prescription Medication2020-02-15
Otsuka America Pharmaceutical, Inc.
Jynarque2020-01-31
Otsuka America Pharmaceutical, Inc.
Jynarque2020-01-31
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.
Prescription Medication2019-08-22
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 Medication2019-07-31
Otsuka America Pharmaceutical, Inc.
Prescription Medication2019-07-25
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.
Prescription Medication2019-04-13
Otsuka America Pharmaceutical, Inc.
Prescription Medication2019-03-30
Otsuka America Pharmaceutical, Inc.
Prescription Medication2019-03-08
Otsuka America Pharmaceutical, Inc., Otsuka Pharmaceutical Co Ltd, Boston Analytical Inc, AndersonBrecon Inc, Eurofins Lancaster Laboratories, Inc, Sharp Corporation
Prescription Medication2019-03-06
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.
Jynarque2018-04-23
Otsuka America Pharmaceutical, Inc.
Jynarque2018-04-23
Otsuka America Pharmaceutical, Inc.
Jynarque2018-04-23
Otsuka America Pharmaceutical, Inc.
JYNARQUE2018-04-23
Otsuka America Pharmaceutical, Inc.
JYNARQUE2018-04-23
Otsuka America Pharmaceutical Inc
BreathTek® UBT for H. pylori Kit (Metabolic Solutions Kit) 2018-03-29
Otsuka America Pharmaceutical, Inc.
Abilify MyCite2018-01-31
Otsuka America Pharmaceutical, Inc.
Abilify MyCite2018-01-31
Otsuka America Pharmaceutical, Inc.
Abilify MyCite2018-01-31
Otsuka America Pharmaceutical, Inc.
Abilify MyCite2018-01-31
Otsuka America Pharmaceutical, Inc.
Abilify MyCite2018-01-31
Otsuka America Pharmaceutical, Inc.
Abilify MyCite2018-01-31
OTSUKA AMERICA PHARMACEUTICAL, INC.
BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.02017-03-30
OTSUKA AMERICA PHARMACEUTICAL, INC.
BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.02017-01-04
OTSUKA AMERICA PHARMACEUTICAL, INC.
BREATH TEK UBT FOR H.PYLORI KIT (BREATH TEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA2016-01-27
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.
REXULTI2015-07-10
Otsuka America Pharmaceutical, Inc.
REXULTI2015-07-10
Otsuka America Pharmaceutical, Inc.
REXULTI2015-07-10
Otsuka America Pharmaceutical, Inc.
REXULTI2015-07-10
Otsuka America Pharmaceutical, Inc.
REXULTI2015-07-10
Otsuka America Pharmaceutical, Inc.
REXULTI2015-07-10
OTSUKA AMERICA PHARMACEUTICAL, INC.
BREATHTEK UBT FOR H.PYLORI KIT2015-03-05
Otsuka America Pharmaceutical, Inc.
BUSULFEX2015-02-13
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 MAINTENA2014-10-08
Otsuka America Pharmaceutical, Inc.
ABILIFY MAINTENA2014-10-08
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 (PUHR2013-05-29
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 MAINTENA2013-02-28
Otsuka America Pharmaceutical, Inc.
ABILIFY MAINTENA2013-02-28
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 KIT2012-09-05
OTSUKA AMERICA PHARMACEUTICAL, INC.
BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.02012-02-22
H.J. Harkins Company, Inc., Otsuka America Pharmaceutical, Inc., Perrigo Nwe York Inc
Prescription Medication2011-12-05
Otsuka America Pharmaceutical, Inc.
SAMSCA2009-05-19
Otsuka America Pharmaceutical, Inc.
SAMSCA2009-05-19
OTSUKA AMERICA PHARMACEUTICAL, INC. [OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALIZATION, INC]
BREATHTEK UBT FOR2007-09-13
Otsuka America Pharmaceutical, Inc.
ABILIFY2006-09-20
Otsuka America Pharmaceutical, Inc.
ABILIFY2006-06-07
Otsuka America Pharmaceutical, Inc.
ABILIFY2006-06-07
Otsuka America Pharmaceutical, Inc.
Dacogen2006-05-02
Otsuka America Pharmaceutical, Inc.
ABILIFY2004-12-10
Otsuka America Pharmaceutical, Inc.
ABILIFY2002-11-15
Otsuka America Pharmaceutical, Inc.
ABILIFY2002-11-15
Otsuka America Pharmaceutical, Inc.
ABILIFY2002-11-15
Otsuka America Pharmaceutical, Inc.
ABILIFY2002-11-15
Otsuka America Pharmaceutical, Inc.
ABILIFY2002-11-15
Otsuka America Pharmaceutical, Inc.
ABILIFY2002-11-15
Otsuka America Pharmaceutical, Inc.
BUSULFEX1999-02-04

Similar & Related FDA Registered Companies

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.