New U.S. Veterinary Biological Establishment Licenses and Permits (new permittees) were issued as

follows:

________________________________________________________________

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

issued 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. 21-01

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 October 01, 2020 and December 31, 2020. These do not include those licenses

reissued to update pertinent information.

Est. Name and Address Est. No. Type

Boehringer Ingelheim Animal Health USA Inc.

Athens, GA

427A Permittee

Zoetis Inc.

Lincoln, NE

190G Permittee

True Name Code Est. Name/No.

Bm86 Immunomodulator I392.R0 Zoetis Inc./Est No. 190G

Bm86 Immunomodulator 9392.R1 Zoetis Inc./Est No. 190

Bovine Rhinotracheitis-Virus Diarrhea-Parainfluenza 3-Respiratory Syncytial

Virus Vaccine, Modified Live Virus

1181.29 Zoetis Inc./Est No. 190

Bovine Rhinotracheitis-Virus Diarrhea-Parainfluenza 3-Respiratory Syncytial

Virus Vaccine, Modified Live Virus, Campylobacter Fetus-Leptospira CanicolaGrippotyphosa-Hardjo-Icterohaemorrhagiae-Pomona Bacterin

44B1.24 Zoetis Inc./Est No. 190

Bronchitis Vaccine, Ark Type, Live Virus 1231.22 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Bronchitis Vaccine, Conn Type, Live Virus 1231.1C Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Bronchitis Vaccine, Mass Type, Live Virus 1232.11 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Bursal Disease Vaccine, Standard & Variant, Live Virus 12B1.02 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Bursal Disease-Marek's Disease Vaccine, Serotype 3, Live Marek's Disease

Vector

1A88.R3 Zoetis Inc./Est No. 190

Bursal Disease-Marek's Disease Vaccine, Serotype 3, Live Marek's Disease

Vector

1A88.R3 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Canine PD-1 Monoclonal Antibody Cancer Immunotherapeutic 9790.00 Intervet Inc./Est No. 165A

Clostridium Perfringens Type A Vaccine, Live Salmonella Vector 1U11.R0 Huvepharma, Inc./Est No. 605

Feline Immunodeficiency Virus Vaccine, Killed Virus 15A5.22 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Foot and Mouth Disease Virus Vaccine, Killed Virus 1FM5.22 Boehringer Ingelheim Animal Health

USA Inc./Est No. 427A

Mannheimia Haemolytica-Pasteurella Multocida Bacterin-Toxoid 7935.03 Bimeda Biologicals, Inc./Est No. 290

An Equal Opportunity Provider and Employer
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 21-01

Page 2

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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:

________________________________________________________________

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

True Name Code Est. Name/No.

Marek's Disease-Newcastle Disease Vaccine, Serotype 3, Live Marek's Disease

Vector

16N1.R3 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Newcastle Disease Vaccine, VG/GA Strain, Live Virus 17A2.V3 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Porcine Reproductive & Respiratory Syndrome Vaccine, Reproductive Form,

Modified Live Virus

19Q1.20 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Porcine Reproductive & Respiratory Syndrome Vaccine, Respiratory Form,

Modified Live Virus

19S1.23 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Porcine Reproductive & Respiratory Syndrome-Circovirus Vaccine, Respiratory

Form, Type 2, Modified Live Virus, Killed Baculovirus Vector

19P9.R1 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Est. Name and Address Est. No. Type

T-Cyte Therapeutics, Inc.

Murrieta, CA

598 Licensee

True Name Code Est. Name/No.

Autogenous Vaccine, Killed Virus 1015.20 Kennebec River Biosciences, Inc./Est

No. 476

Autogenous Vaccine, Killed Virus, Autogenous Bacterin 4500.20 Kennebec River Biosciences, Inc./Est

No. 476

Bluetongue Virus Antibody Test Kit 5010.00 Veterinary Diagnostic Technology,

Inc./Est No. 336

Bluetongue Virus Antibody Test Kit, cELISA 5010.20 Veterinary Diagnostic Technology,

Inc./Est No. 336

Bovine Leukemia Virus Antibody Test Kit 5505.20 Veterinary Diagnostic Technology,

Inc./Est No. 336

Bovine Rhinotracheitis-Virus Diarrhea-Parainfluenza 3-Respiratory Syncytial

Virus Vaccine, Killed Virus, Leptospira Canicola-Grippotyphosa-HardjoIcterohaemorrhagiae-Pomona-Mannheimia Haemolytica Bacterin

4475.20 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Bursal Disease-Marek's Disease-Newcastle Disease Vaccine, Serotype 3, Live

Marek's Disease Vector

1A89.R1 Biomune Company/Est No. 368

Canine Osteosarcoma Vaccine, Live Listeria Vector 9243.R0 Huvepharma, Inc./Est No. 605

Caprine Arthritis-Encephalitis-Ovine Progressive Pneumonia Virus Antibody

Test Kit

5140.00 Veterinary Diagnostic Technology,

Inc./Est No. 336

Epizootic Hemorrhagic Disease Virus Antibody Test Kit 5A27.00 Veterinary Diagnostic Technology,

Inc./Est No. 336

Glaesserella Parasuis Vaccine, Avirulent Live Culture 19J1.00 Newport Laboratories, Inc./Est No. 455

Lymphocyte T-Cell Immunomodulator 9410.00 T-Cyte Therapeutics, Inc./Est No. 598

Mycoplasma Hyopneumoniae Bacterin B775.07 Pharmgate Biologics, Inc./Est No. 329

Parvovirus Vaccine, Killed Virus, Erysipelothrix Rhusiopathiae-Leptospira

Canicola-Grippotyphosa-Hardjo-Icterohaemorrhagiae-Pomona Bacterin

48C5.21 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Porcine Reproductive & Respiratory Syndrome-Parvovirus Vaccine,

Reproductive Form, Modified Live & Killed Virus, Erysipelothrix

Rhusiopathiae-Leptospira Canicola-Grippotyphosa-Hardjo-IcterohaemorrhagiaePomona Bacterin

4P19.20 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

An Equal Opportunity Provider and Employer