There were no new U.S. Veterinary Biologics Establishment Licenses or Permits (new permittees)

issued this quarter.

________________________________________________________________

New U.S. Veterinary Biologics Product Licenses and Biological Product Permits (new codes) were

issued as follows:

________________________________________________________________

U.S. Veterinary Biologics Establishment Licenses and Permits (Permittees) were terminated without

prejudice as follows:

________________________________________________________________

U.S. Veterinary Biological Product Licenses and Permits (codes) were terminated without prejudice

as follows:

United States Department of Agriculture

Animal and Plant

Health Inspection

Services

Veterinary Services

Center for Veterinary

Biologics

1920 Dayton Ave

PO Box 844

Ames, IA 50010

(515) 337-6100

CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 24-02

TO:

FROM:

SUBJECT:

Biologics Licensees, Permittees, and Applicants

Directors, Center for Veterinary Biologics

Veterinary Services Leadership Team

Geetha Srinivas

Director

Issuance of Licenses

The purpose of this notice is to bring to the attention of interested parties licenses issued and

terminated between October 01, 2023 and December 31, 2023. These do not include those licenses

reissued to update pertinent information.

True Name Code Est. Name/No.

Escherichia Coli Vaccine, Avirulent Live Culture 1551.03 ARKO Laboratories, Ltd./Est No. 337

Rabbit Hemorrhagic Disease Vaccine, Serotype 2, Killed Baculovirus Vector 1R00.R0 Medgene Labs/Est No. 474

Est. Name and Address Est. No. Type

Delmont Laboratories, Inc.

Swarthmore, PA

339 Licensee

True Name Code Est. Name/No.

Autogenous Vaccine, Killed Virus A015.21 Cambridge Technologies/Est No. 464

Avian Encephalomyelitis Vaccine, Live Virus 1051.10 Ceva Animal Health, LLC/Est No. 368

Avian Influenza Vaccine, H5N9 Subtype, Killed Virus 1057.14 Ceva Animal Health, LLC/Est No. 368

Bovine Rhinotracheitis-Virus Diarrhea-Parainfluenza 3-Respiratory Syncytial

Virus Vaccine, Modified Live Virus

1181.21 Zoetis Inc./Est No. 190

Bovine Rhinotracheitis-Virus Diarrhea-Parainfluenza 3-Respiratory Syncytial

Virus Vaccine, Modified Live Virus, Haemophilus Somnus Bacterin

44C9.20 Zoetis Inc./Est No. 190

Bronchitis Vaccine, Ark Type, Live Virus 1231.1M Ceva Animal Health, LLC/Est No. 368

An Equal Opportunity Provider and Employer
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 24-02

Page 2

________________________________________________________________

There were no Product Licenses or Permits (codes) issued due to an acquisition this quarter.

True Name Code Est. Name/No.

Bronchitis Vaccine, Mass & Ark Types, Live Virus 1231.1Q Ceva Animal Health, LLC/Est No. 368

Bronchitis Vaccine, Mass & Conn Types, Live Virus 1231.14 Ceva Animal Health, LLC/Est No. 368

Bronchitis Vaccine, Mass & Conn Types, Live Virus 1231.17 Ceva Animal Health, LLC/Est No. 368

Bronchitis Vaccine, Mass Type, Killed Virus 1235.10 Ceva Animal Health, LLC/Est No. 368

Bursal Disease Vaccine, Live Virus 1271.04 Ceva Animal Health, LLC/Est No. 368

Bursal Disease Vaccine, Live Virus 1271.01 Ceva Animal Health, LLC/Est No. 368

Bursal Disease-Marek's Disease Vaccine, Serotypes 1 & 2 & 3, Live Virus, Live

Marek's Disease Vector

1281.R0 Ceva Animal Health, LLC/Est No. 368

Bursal Disease-Marek's Disease Vaccine, Serotypes 2 & 3, Live Virus, Live

Marek's Disease Vector

1A88.R1 Ceva Animal Health, LLC/Est No. 368

Bursal Disease-Marek's Disease-Newcastle Disease Vaccine, Serotypes 2 & 3,

Live Virus, Live Marek's Disease Vector

1A91.R0 Ceva Animal Health, LLC/Est No. 368

Canine Distemper-Adenovirus Type 2-Parainfluenza-Parvovirus Vaccine,

Modified Live Virus

13D1.21 Zoetis Inc./Est No. 190

Canine Distemper-Adenovirus Type 2-Parainfluenza-Parvovirus Vaccine,

Modified Live Virus, Leptospira Canicola-Icterohaemorrhagiae Bacterin

4639.21 Zoetis Inc./Est No. 190

Canine Influenza Vaccine, H3N8, Killed Virus 15K5.20 Zoetis Inc./Est No. 190

Canine Rheumatoid Factor Antigen Test Kit 5012.00 Zoetis Inc./Est No. 190

Feline Leukemia Vaccine, Killed Virus A555.21 Zoetis Inc./Est No. 190

Feline Leukemia Vaccine, Killed Virus 1555.21 Zoetis Inc./Est No. 190

Feline Leukemia Virus Antigen Test Kit 5028.02 Zoetis Inc./Est No. 190

Marek's Disease Vaccine, Serotype 2, Live Virus 1631.00 Ceva Animal Health, LLC/Est No. 368

Marek's Disease Vaccine, Serotypes 1 & 2 & 3, Live Virus 16L1.01 Ceva Animal Health, LLC/Est No. 368

Marek's Disease-Newcastle Disease Vaccine, Serotypes 1 & 2 & 3, Live Virus,

Live Marek's Disease Vector

16N1.R2 Ceva Animal Health, LLC/Est No. 368

Marek's Disease-Newcastle Disease Vaccine, Serotypes 2 & 3, Live Virus, Live

Marek's Disease Vector

17H1.R1 Ceva Animal Health, LLC/Est No. 368

Mycobacterium Avium subspecies Paratuberculosis Antibody Test Kit 5064.01 Zoetis Inc./Est No. 190

Newcastle Disease Vaccine, B1 Type, LaSota Strain, Live Virus 1721.10 Ceva Animal Health, LLC/Est No. 368

Newcastle Disease Vaccine, Killed Virus 1705.10 Ceva Animal Health, LLC/Est No. 368

Pasteurella Multocida Vaccine, Avirulent Live Culture, Avian Isolate 1871.03 Ceva Animal Health, LLC/Est No. 368

Swine Influenza Virus Type A Antigen Test Kit 5181.51 Zoetis Inc./Est No. 190

Tetanus Toxoid H601.02 Hennessy Research Associates,

LLC/Est No. 597

An Equal Opportunity Provider and Employer