otsuka-us.comABILIFY
ARIPIPRAZOLE
OTSUKA
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3005622096 | 3005622096 | OTSUKA ELECTRONICS CO., LTD. | 1 | N | 2026-01-01 | 1-10, Sasagaoka, Minakuchi-cho Koka-city Shiga JP 528-0061 |
| 3010447004 | 3010447004 | Otsuka Precision Health, Inc. | 1 | N | 2026-01-01 | 508 Carnegie Ctr Princeton NJ US 08540 |
| 3010742884 | 3010742884 | Otsuka America Pharmaceutical, Inc | 1 | N | 2026-01-01 | 3956 Point Eden Way Hayward CA US 94545 |
| 3000718406 | 3000718406 | OTSUKA AMERICA PHARMACEUTICAL, INC. | 1 | Y | 2020-04-25 | 2440 Research Blvd Rockville MD US 20850 |
| 3006532887 | 3002809299 | OTSUKA PHARMACEUTICAL CO., LTD. TOKUSHIMA FACTORY | 1 | N | 2020-04-25 | 463-10 KAGASUNO, KAWAUCHI-CHO TOKUSHIMA Tokusima JP 771-0192 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00857335005053 | MyCite Patch - DW5 replacement patch | 609.535.9659 | michael.fahmy@otsuka-us.com |
| 00857335005053 | MyCite Patch - DW5 replacement patch | 410-353-8778 | nancy.teague@otsuka-us.com |
| 00857335005091 | MyCite Patch - 2 component patch RW2 | 609.535.9659 | michael.fahmy@otsuka-us.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 68847 | 1993667191 | P100025 | BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0 | OZA | 2012-02-22 |
| 283076 | 1490004324 | K251088 | Otsuka Digital Feedback Device | OZW | 2025-06-30 |
| 346820 | 1417100988 | K231209 | Rejoyn | SAP | 2024-03-30 |
| 68847 | 2021951238 | K014225 | BREATHTEK - UBIT UBT FOR H. PYLORI | MSQ | 2002-01-17 |
| 13129 | 1172035846 | ||||
| 13129 | 1547979732 | ||||
| 349412 | 1445620418 |
Product Codes Associated With Registrations#
NDC#
ABILIFY
ARIPIPRAZOLE
ABILIFY
ARIPIPRAZOLE
ABILIFY
ARIPIPRAZOLE
ABILIFY
ARIPIPRAZOLE
ABILIFY
ARIPIPRAZOLE
SAMSCA
tolvaptan
SAMSCA
tolvaptan
Rexulti
brexpiprazole
Rexulti
brexpiprazole
Rexulti
brexpiprazole
Rexulti
brexpiprazole
Rexulti
brexpiprazole
Rexulti
brexpiprazole
Rexulti
BREXPIPRAZOLE
Rexulti
BREXPIPRAZOLE
ABILIFY MAINTENA
aripiprazole
Nuedexta
dextromethorphan hydrobromide and quinidine sulfate
BUSULFEX
busulfan
ABILIFY MAINTENA
aripiprazole
Jynarque
tolvaptan
Jynarque
tolvaptan
JYNARQUE
tolvaptan
JYNARQUE
tolvaptan
Jynarque
tolvaptan
Jynarque
tolvaptan
Jynarque
tolvaptan
Abilify Asimtufii
Aripiprazole
Abilify Asimtufii
Aripiprazole
ABILIFY MAINTENA
aripiprazole
ABILIFY MAINTENA
aripiprazole
VOYXACT
sibeprenlimab
PMA#
BreathTek UBT for H. pylori Kit and Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA)
OTSUKA AMERICA PHARMACEUTICAL, INC.
BreathTek UBT for H.pylori Kit (BreathTek UBT Kit), Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA)
OTSUKA AMERICA PHARMACEUTICAL, INC.
BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0
OTSUKA AMERICA PHARMACEUTICAL, INC.
BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0
OTSUKA AMERICA PHARMACEUTICAL, INC.
BREATH TEK UBT FOR H.PYLORI KIT (BREATH TEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA
OTSUKA AMERICA PHARMACEUTICAL, INC.
BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA)
OTSUKA AMERICA PHARMACEUTICAL, INC.
BREATHTEK UBT FOR H.PYLORI KIT
OTSUKA AMERICA PHARMACEUTICAL, INC.
BREATH TEK UBT FOR H PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PHUR-CA)
OTSUKA AMERICA PHARMACEUTICAL, INC.
BREATHTEK UBT FOR H.PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA)
OTSUKA AMERICA PHARMACEUTICAL, INC.
BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA)
OTSUKA AMERICA PHARMACEUTICAL, INC.
BREATH TEK UBT FOR H. PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR
OTSUKA AMERICA PHARMACEUTICAL, INC.
BREATH TEK UBT FOR H PYLORI KIT (BREATH TEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION(PUHR-CA)
OTSUKA AMERICA PHARMACEUTICAL, INC.
BREATHTEK UBT FOR H. PYLORI HIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE APPLICATION (PUHR-CA)
OTSUKA AMERICA PHARMACEUTICAL, INC.
BREATH TEK UBTFOR H. PYLORI KIT
OTSUKA AMERICA PHARMACEUTICAL, INC.
BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0
OTSUKA AMERICA PHARMACEUTICAL, INC.
PMN#
Rejoyn
Otsuka America Pharmaceutical, Inc.
Otsuka Digital Feedback Device-RW
Otsuka America Pharmaceutical, Inc.
POC-AS10 AUTO SAMPLER
OTSUKA PHARMACEUTICAL CO., LTD.
RAPIRUN H. PYLORI ANTIBODY DETECTION KIT
OTSUKA PHARMACEUTICAL CO., LTD.
POCONE INFRARED SPECTROPHOTOMETER
OTSUKA PHARMACEUTICAL CO., LTD.
UBIT-IR300 INFRARED SPECTROMETRY SYSTEM
OTSUKA PHARMACEUTICAL CO., LTD.
RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY
OTSUKA PHARMACEUTICAL CO., LTD.
RLP CHOLESTEROL IMMUNOSEPARATION ASSAY
OTSUKA PHARMACEUTICAL CO., LTD.
ORACLE MRI WHOLE BODY MR IMAGING SYSTEM
OTSUKA ELECTRONICS USA, INC.
MAGNETIC RESONANCE ANGIOGRAPHY CAPABILITY/OE 1.5 S1
OTSUKA ELECTRONICS USA, INC.
OE 1.5 SI
OTSUKA ELECTRONICS
MRI OE 1.5 SI
OTSUKA ELECTRONICS
Applications#
GUDID#
Otsuka Digital Feedback Device - The wearable sensor in the Otsuka Digital Feedback Device is a body-worn sensor that consists of a single-use patch known as the D-Tect wearable sensor or D-Tect Patch. The D-Tect Patch collects physiological and behavioral metrics such as heart rate, activity, body angle, and time stamped patient-logged events, including events signaled by the co-incidence with, or co-ingestion with, the ingestible sensor accessory. Note: While the device includes automated heart rate (HR) measurement, it does not provide an ECG waveform recording for display or analysis. The device is not intended to diagnose heart-related conditions and does not include alarms. HR measurement is not intended to be used in alarm system. HR data may not be accurate for patients with pacemakers.
2026-05-11
Rejoyn - Rejoyn (also known as CT-152) is a digital therapeutic smartphone application (app) for the treatment of Major Depressive Disorder (MDD) symptoms. Rejoyn is a prescription smartphone app-based digital therapeutic administered to a user via the user’s smartphone device (running Apple iPhone operating system [iOS®] or Android™ operating system [OS]), which delivers a proprietary interactive cognitive emotional and behavioral therapeutic intervention. The core components of Rejoyn are the Emotional Faces Memory Task (EFMT) exercises, brief cognitive behavioral therapy (CBT)-based lessons to learn and apply key therapeutic skills, and short message service (SMS) text messaging to reinforce CBT-based lesson content and to encourage engagement with the app. It is intended for the treatment of MDD symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD aged 22 years and older. It is intended to reduce MDD symptoms. Rejoyn is designed for use as an adjunct to clinician-managed outpatient care over a period of 6 weeks for the treatment of MDD symptoms, followed by a 4-week extension period where CBT-based lesson content will be accessible but no new therapeutic content or EFMT exercises will be available. Rejoyn is not intended to be used as a stand-alone therapy or as a substitution for the patient’s clinician prescribed medications.
2024-07-02
Rejoyn - Rejoyn (also known as CT-152) is a digital therapeutic smartphone application (app) for the treatment of Major Depressive Disorder (MDD) symptoms. Rejoyn is a prescription smartphone app-based digital therapeutic administered to a user via the user’s smartphone device (running Apple iPhone operating system [iOS®] or Android™ operating system [OS]), which delivers a proprietary interactive cognitive emotional and behavioral therapeutic intervention. The core components of Rejoyn are the Emotional Faces Memory Task (EFMT) exercises, brief cognitive behavioral therapy (CBT)-based lessons to learn and apply key therapeutic skills, and short message service (SMS) text messaging to reinforce CBT-based lesson content and to encourage engagement with the app. It is intended for the treatment of MDD symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD aged 22 years and older. It is intended to reduce MDD symptoms. Rejoyn is designed for use as an adjunct to clinician-managed outpatient care over a period of 6 weeks for the treatment of MDD symptoms, followed by a 4-week extension period where CBT-based lesson content will be accessible but no new therapeutic content or EFMT exercises will be available. Rejoyn is not intended to be used as a stand-alone therapy or as a substitution for the patient’s clinician prescribed medications.
2026-01-05
Rejoyn - Rejoyn (also known as CT-152) is a digital therapeutic smartphone application (app) for the treatment of Major Depressive Disorder (MDD) symptoms. Rejoyn is a prescription smartphone app-based digital therapeutic administered to a user via the user’s smartphone device (running Apple iPhone operating system [iOS®] or Android™ operating system [OS]), which delivers a proprietary interactive cognitive emotional and behavioral therapeutic intervention. The core components of Rejoyn are the Emotional Faces Memory Task (EFMT) exercises, brief cognitive behavioral therapy (CBT)-based lessons to learn and apply key therapeutic skills, and short message service (SMS) text messaging to reinforce CBT-based lesson content and to encourage engagement with the app. It is intended for the treatment of MDD symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD aged 22 years and older. It is intended to reduce MDD symptoms. Rejoyn is designed for use as an adjunct to clinician-managed outpatient care over a period of 6 weeks for the treatment of MDD symptoms, followed by a 4-week extension period where CBT-based lesson content will be accessible but no new therapeutic content or EFMT exercises will be available. Rejoyn is not intended to be used as a stand-alone therapy or as a substitution for the patient’s clinician prescribed medications.
2026-01-05
MyCite Patch - DW5 replacement patch
2021-01-08
MyCite Patch - 2 component patch RW2
2021-04-14
POC-AS10 Auto sampler - The POC-ASI10 Auto sampler expands the number of breath collection bags that can be set up and analyzed by the POCone Infrared Spectrophotometer.
2019-10-30
POCone Infrared Spectrophotometer - The POCone Infrared Spectrophotometer is an in vitro diagnostic device designed to measure changes in 13CO2 content in breath CO2 gas by infrared spectroscopic analysis.The POCone Infrared Spectrophotometer is intended for use in conjunction with commercially available Meretek 13C-urea breath tests for the detection of Helicobacterpylori (H. pylon) infection. The POCone Infrared Spectrophotometer is suitable for use in both point of care and clinical laboratory settings.
2019-10-30
Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA - The web based application for calculating pediatric urea hydrolysis rate as part of the BreathTek UBT Kit for H. pylori.
2017-04-19
Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA - The web based application for calculating pediatric urea hydrolysis rate as part of the BreathTek UBT Kit for H. pylori.
2014-09-23
BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) - The BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) is intended for use in the qualitative detection of urease associated with H. pylori in the human stomach and is indicated as an aid in the initial diagnosis and post-treatment monitoring of H. pylori infection in adults, and pediatric patients 3 to 17 years old. The test may be used for monitoring treatment if used at least 4 weeks following completion of therapy. For these purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ratio of 13CO2 to 12CO2 in breath samples, in clinical laboratories and point-of-care settings. The Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), provided as a web-based calculation program, is required to obtain pediatric test results.The BreathTek UBT Kit is for administration by a health care professional, as ordered by a licensed health care practitioner.
2017-05-16
BreathTek® UBT for H. pylori Kit (Metabolic Solutions Kit) - This is the Metabolic Solutions Kit version of the kit.
2017-05-16