FDA.reportPublic FDA data

OTSUKA AMERICA PHARMACEUTICAL, INC.

Matched from indexed company URL: Otsuka America Pharmaceutical, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30007184063000718406OTSUKA AMERICA PHARMACEUTICAL, INC.1Y2020-04-252440 Research Blvd Rockville MD US 20850

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
688472021951238K014225BREATHTEK - UBIT UBT FOR H. PYLORIMSQ2002-01-17

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OZA12012-02-22
MSQ12002-01-17

NDC#

PMA#

PMN#