otsuka-us.comABILIFY
ARIPIPRAZOLE
Otsuka America Pharmaceutical, Inc
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 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 |
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 |
| 68847 | 2021951238 | K014225 | BREATHTEK - UBIT UBT FOR H. PYLORI | MSQ | 2002-01-17 |
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.
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
MyCite Patch - DW5 replacement patch
2021-01-08
MyCite Patch - 2 component patch RW2
2021-04-14
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