Otsuka Pharmaceutical Development Commercialization Inc

FDA Filings

This page includes the latest FDA filings for Otsuka Pharmaceutical Development Commercialization Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3000718406
• FEI Number: 3000718406
• Name: OTSUKA AMERICA PHARMACEUTICAL, INC.
• Owner & Operator: OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALIZATION, INC
• Contact Address: 2440 RESEARCH BLVD. --; Rockville MD 20850 US
• Official Correspondent:
  • Michael Fahmy
  • x-609-5359659-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 2440 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	Device	Date
GUDID 00857335005121 Otsuka Pharmaceutical Development & Commercialization, Inc.	Rejoyn 57335000512	2024-07-10
PMN P100025 | OZA 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
PMN K014225 | MSQ OTSUKA AMERICA PHARMACEUTICAL, INC. [OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALIZATION, INC]	BREATHTEK UBT FOR	2007-09-13

Related Finance Registrations

NCAGE Code	7ZLN3	OTSUKA PHARMACEUTICAL DEVELOPMENT &!COMMERCIALIZATION, INC.
CAGE Code	7ZLN3	OTSUKA PHARMACEUTICAL DEVELOPMENT & COMMERCIALIZATION, INC.
S.A.M. Registration	7ZLN3 [126812382]	OTSUKA PHARMACEUTICAL DEVELOPMENT & COMMERCIALIZATION, INC.
DUNS	126812382	Otsuka Pharmaceutical Development & Commercialization, Inc.