FDA.reportPublic FDA data

OTSUKA

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30056220963005622096OTSUKA ELECTRONICS CO., LTD.1N2026-01-011-10, Sasagaoka, Minakuchi-cho Koka-city Shiga JP 528-0061
30104470043010447004Otsuka Precision Health, Inc.1N2026-01-01508 Carnegie Ctr Princeton NJ US 08540
30107428843010742884Otsuka America Pharmaceutical, Inc1N2026-01-013956 Point Eden Way Hayward CA US 94545
30007184063000718406OTSUKA AMERICA PHARMACEUTICAL, INC.1Y2020-04-252440 Research Blvd Rockville MD US 20850
30065328873002809299OTSUKA PHARMACEUTICAL CO., LTD. TOKUSHIMA FACTORY1N2020-04-25463-10 KAGASUNO, KAWAUCHI-CHO TOKUSHIMA Tokusima JP 771-0192

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00857335005053MyCite Patch - DW5 replacement patch609.535.9659michael.fahmy@otsuka-us.com
00857335005053MyCite Patch - DW5 replacement patch410-353-8778nancy.teague@otsuka-us.com
00857335005091MyCite Patch - 2 component patch RW2609.535.9659michael.fahmy@otsuka-us.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
688471993667191P100025BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0OZA2012-02-22
2830761490004324K251088Otsuka Digital Feedback DeviceOZW2025-06-30
3468201417100988K231209RejoynSAP2024-03-30
688472021951238K014225BREATHTEK - UBIT UBT FOR H. PYLORIMSQ2002-01-17
131291172035846
131291547979732
3494121445620418

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OZW12025-06-30
SAP12024-03-30
OZA12012-02-22
MSQ12002-01-17

NDC#

ABILIFY

Otsuka America Pharmaceutical, Inc.

ARIPIPRAZOLE

ABILIFY

Otsuka America Pharmaceutical, Inc.

ARIPIPRAZOLE

ABILIFY

Otsuka America Pharmaceutical, Inc.

ARIPIPRAZOLE

ABILIFY

Otsuka America Pharmaceutical, Inc.

ARIPIPRAZOLE

ABILIFY

Otsuka America Pharmaceutical, Inc.

ARIPIPRAZOLE

ABILIFY

Otsuka America Pharmaceutical, Inc.

ARIPIPRAZOLE

SAMSCA

Otsuka America Pharmaceutical, Inc.

tolvaptan

SAMSCA

Otsuka America Pharmaceutical, Inc.

tolvaptan

Rexulti

Otsuka America Pharmaceutical, Inc.

brexpiprazole

Rexulti

Otsuka America Pharmaceutical, Inc.

brexpiprazole

Rexulti

Otsuka America Pharmaceutical, Inc.

brexpiprazole

Rexulti

Otsuka America Pharmaceutical, Inc.

brexpiprazole

Rexulti

Otsuka America Pharmaceutical, Inc.

brexpiprazole

Rexulti

Otsuka America Pharmaceutical, Inc.

brexpiprazole

Rexulti

Otsuka America Pharmaceutical, Inc.

BREXPIPRAZOLE

Rexulti

Otsuka America Pharmaceutical, Inc.

BREXPIPRAZOLE

Nuedexta

Otsuka America Pharmaceutical, Inc

dextromethorphan hydrobromide and quinidine sulfate

BUSULFEX

Otsuka America Pharmaceutical, Inc.

busulfan

Jynarque

Otsuka America Pharmaceutical, Inc.

tolvaptan

Jynarque

Otsuka America Pharmaceutical, Inc.

tolvaptan

JYNARQUE

Otsuka America Pharmaceutical, Inc.

tolvaptan

JYNARQUE

Otsuka America Pharmaceutical, Inc.

tolvaptan

Jynarque

Otsuka America Pharmaceutical, Inc.

tolvaptan

Jynarque

Otsuka America Pharmaceutical, Inc.

tolvaptan

Jynarque

Otsuka America Pharmaceutical, Inc.

tolvaptan

VOYXACT

Otsuka America Pharmaceutical, Inc.

sibeprenlimab

PMA#

PMN#

Rejoyn

2024-03-30

Otsuka America Pharmaceutical, Inc.

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.

Otsuka America Pharmaceutical Inc

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.

Otsuka Pharmaceutical Development & Commercialization, Inc.

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.

Otsuka Precision Health, Inc

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.

Otsuka Precision Health, Inc

2026-01-05

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.

OTSUKA ELECTRONICS CO.,LTD.

2019-10-30

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.

Otsuka America Pharmaceutical Inc

2017-05-16