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:

________________________________________________________________

There were no U.S. Veterinary Biologics Establishment Licenses or Permits (Permittees) terminated

this quarter.

________________________________________________________________

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. 20-09

TO: Biologics Licensees, Permittees, and Applicants

Directors, Center for Veterinary Biologics

Veterinary Services Leadership Team

FROM: Byron Rippke

Director

SUBJECT: Issuance of Licenses

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

terminated between July 01, 2020 and September 30, 2020. These do not include those licenses

reissued to update pertinent information.

True Name Code Est. Name/No.

Bovine Rhinotracheitis-Parainfluenza 3-Respiratory Syncytial Virus-Mannheimia

Haemolytica-Pasteurella Multocida Vaccine, Modified Live Virus, Avirulent

Live Culture

11C8.20 Intervet Inc./Est No. 165A

Bursal Disease-Infectious Laryngotracheitis-Marek's Disease Vaccine, Serotype

3, Live Marek's Disease Vector

1J81.R0 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Epizootic Bovine Abortion Agent Vaccine, Live Culture 1544.00 Hygieia Biological Laboratories/Est

No. 407

Porcine Reproductive & Respiratory Syndrome Vaccine, Reproductive &

Respiratory Forms, Modified Live Virus

19T1.20 Elanco US Inc./Est No. 196

True Name Code Est. Name/No.

Bronchitis Vaccine, Mass Type, Killed Virus 1235.10 Elanco US Inc./Est No. 196

Bursal Disease Virus, Live Variant A2B9.42 Kestrel, Inc./Est No. 415

Bursal Disease Virus, Live Virus A3B1.00 Kestrel, Inc./Est No. 415

Bursal Disease Virus, Variant Strain, Live Virus A2B9.40 Kestrel, Inc./Est No. 415

Equine Infectious Anemia Virus Antibody Test Kit 5515.21 Zoetis Inc./Est No. 190

An Equal Opportunity Provider and Employer
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 20-09

Page 2

________________________________________________________________

Due to acquisitions, U.S. Veterinary Biological Product Licenses and Permits have been issued as

follows:

True Name Code Est. Name/No.

Heartworm Antigen Test Kit 5018.03 Diamond Animal Health, Inc./Est No.

213

Heartworm Antigen Test Kit 5018.01 Zoetis Inc./Est No. 190

Pullorum Antigen, Stained Antigen Polyvalent 5207.00 Elanco US Inc./Est No. 196

Trichinella Spiralis Antibody Test Kit 5350.00 Safepath Laboratories/Est No. 430

Previous Est.

No./Prod Code

True Name Code Purchasing Est. Name/No.

Identical to Code

4637.29 (licensed)

except that

production moved

from Fort Dodge site

to Athens as part of

FTC divestiture.

Fallout of Code

46J9.23.

Canine Distemper-Adenovirus Type 2-Parainfluenza-Parvovirus

Vaccine, Modified Live Virus, Leptospira CanicolaGrippotyphosa-Icterohaemorrhagiae-Pomona Bacterial Extract

4637.24 Boehringer Ingelheim Animal

Health USA Inc./Est No. 124

Formerly Code

2668.05.

Leptospira Canicola-Grippotyphosa-IcterohaemorrhagiaePomona Bacterial Extract2668.06 Boehringer Ingelheim Animal

Health USA Inc./Est No. 124

An Equal Opportunity Provider and Employer