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. 21-06

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 April 01, 2021 and June 30, 2021. These do not include those licenses

reissued to update pertinent information.

True Name Code Est. Name/No.

Autogenous Vaccine, Killed Virus, Autogenous Bacterin 4500.20 Medgene Labs/Est No. 474

Clostridium Perfringens Type A Vaccine, Live Salmonella Vector 1U11.R1 Huvepharma, Inc./Est No. 605

Foot and Mouth Disease Virus RNA Test Kit 5FM1.81 Tetracore, Inc./Est No. 644

Rabies Vaccine, Killed Virus A905.21 Zoetis Inc./Est No. 190

Est. Name and Address Est. No. Type

TechLab, Inc. 446 Licensee

True Name Code Est. Name/No.

Actinobacillus Pleuropneumoniae Bacterin 2657.01 Elanco US Inc./Est No. 196

Actinobacillus Pleuropneumoniae-Bordetella Bronchiseptica-Erysipelothrix

Rhusiopathiae-Glaesserella Parasuis-Pasteurella Multocida Bacterin

2110.00 Elanco US Inc./Est No. 196

Actinobacillus Pleuropneumoniae-Pasteurella Multocida Bacterin 265H.01 Elanco US Inc./Est No. 196

Antivenin, Crotalidae Polyvalent 6101.00 Elanco US Inc./Est No. 196

Bovine Rhinotracheitis-Parainfluenza 3 Vaccine, Modified Live Virus 1121.20 Elanco US Inc./Est No. 196

Brucella Suis Bacterin 2127.00 Newport Laboratories, Inc./Est No. 455

An Equal Opportunity Provider and Employer
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 21-06

Page 2

________________________________________________________________

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

True Name Code Est. Name/No.

Clostridium Perfringens Type C Antitoxin, Equine Origin 6211.01 Elanco US Inc./Est No. 196

Clostridium Perfringens Type C Antitoxin-Escherichia Coli Antibody, Equine

Origin

6212.01 Elanco US Inc./Est No. 196

Clostridium Perfringens Types C & D Antitoxin, Equine Origin 6221.00 Elanco US Inc./Est No. 196

Clostridium Perfringens Types C & D Bacterin-Toxoid 7870.00 Elanco US Inc./Est No. 196

Corynebacterium Pseudotuberculosis Bacterin 2A94.00 Bimeda Biologicals, Inc./Est No. 290

Erysipelothrix Rhusiopathiae Bacterin 2641.02 Elanco US Inc./Est No. 196

Escherichia Coli Antibody, Equine Origin 3526.00 Elanco US Inc./Est No. 196

Giardia Antigen Test Kit 5G05.20 TechLab, Inc./Est No. 446

Glaesserella Parasuis-Mycoplasma Hyopneumoniae Bacterin 2565.04 Zoetis Inc./Est No. 190

Heartworm Antigen Test Kit 5018.02 Diamond Animal Health, Inc./Est No.

213

Heartworm Antigen Test Kit 5018.01 Diamond Animal Health, Inc./Est No.

213

Parvovirus Vaccine, Killed Virus, Erysipelothrix Rhusiopathiae-Leptospira

Canicola-Grippotyphosa-Hardjo-Icterohaemorrhagiae-Pomona Bacterin

D8C5.20 Elanco US Inc./Est No. 196

Serpens Species Bacterin 21B5.00 Hygieia Biological Laboratories/Est

No. 407

An Equal Opportunity Provider and Employer