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. 20-03

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 January 01, 2020 and March 31, 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 Vaccine,

Modified Live Virus

1071.20 Intervet Inc./Est No. 165A

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

Live Marek's Disease Vector

16J1.R4 Biomune Company/Est No. 368

Prescription Product, DNA 9PP0.R1 Huvepharma, Inc./Est No. 605

Prescription Product, Killed Baculovirus Vector 9PP0.R0 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Salmonella Enteritidis Bacterial Extract 27A5.02 Epitopix, LLC/Est No. 365

Swine Influenza Vaccine, DNA 19A5.D3 Huvepharma, Inc./Est No. 605

Est. Name and Address Est. No. Type

Abaxis, Inc.

Union City, CA

424 Licensee

True Name Code Est. Name/No.

Anaplasmosis Vaccine, Avirulent Live Culture 1001.C0 Poultry Health Laboratories/Est No.

357

An Equal Opportunity Provider and Employer
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 20-03

Page 2

True Name Code Est. Name/No.

Bluetongue Vaccine, Serotype 10, Modified Live Virus 1061.C1 Poultry Health Laboratories/Est No.

357

Bluetongue Vaccine, Serotype 11, Modified Live Virus 1061.C2 Poultry Health Laboratories/Est No.

357

Bluetongue Vaccine, Serotype 17, Modified Live Virus 1061.C0 Poultry Health Laboratories/Est No.

357

Bordetella Bronchiseptica Vaccine, Avirulent Live Culture 1081.00 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Bordetella Bronchiseptica Vaccine, Avirulent Live Culture 1081.00 Elanco US Inc./Est No. 196

Bordetella Bronchiseptica-Pasteurella Multocida Bacterin-Toxoid 7060.00 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Borrelia Burgdorferi Bacterin 2126.00 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Borrelia Burgdorferi Bacterin-Leptospira Canicola-GrippotyphosaIcterohaemorrhagiae-Pomona Bacterial Extract2146.00 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Bovine Rhinotracheitis Vaccine, Modified Live Virus 1101.21 Elanco US Inc./Est No. 196

Bovine Rhinotracheitis-Parainfluenza 3-Respiratory Syncytial Virus Vaccine,

Modified Live Virus

1071.21 Elanco US Inc./Est No. 196

Bovine Rhinotracheitis-Virus Diarrhea Vaccine, Modified Live Virus 1151.26 Elanco US Inc./Est No. 196

Bovine Rhinotracheitis-Virus Diarrhea-Parainfluenza 3-Respiratory Syncytial

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

4475.20 Elanco US Inc./Est No. 196

Bovine Rhinotracheitis-Virus Diarrhea-Parainfluenza 3-Respiratory Syncytial

Virus Vaccine, Killed Virus, Mannheimia Haemolytica Bacterin

44A5.20 Elanco US Inc./Est No. 196

Bovine Rhinotracheitis-Virus Diarrhea-Parainfluenza 3-Respiratory Syncytial

Virus Vaccine, Modified Live Virus

1181.25 Elanco US Inc./Est No. 196

Bovine Rhinotracheitis-Virus Diarrhea-Parainfluenza 3-Respiratory Syncytial

Virus Vaccine, Modified Live Virus

1181.26 Elanco US Inc./Est No. 196

Campylobacter Fetus-Leptospira Canicola-Grippotyphosa-HardjoIcterohaemorrhagiae-Pomona Bacterin2863.10 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Campylobacter Fetus-Leptospira Canicola-Grippotyphosa-HardjoIcterohaemorrhagiae-Pomona Bacterin2863.10 Elanco US Inc./Est No. 196

Canine Anaplasma Antibody Test Kit 5751.20 Abaxis, Inc./Est No. 424

Canine Borrelia Burgdorferi Antibody Test Kit 5017.50 Abaxis, Inc./Est No. 424

Canine Coronavirus Vaccine, Killed Virus 14P5.22 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Canine Coronavirus Vaccine, Killed Virus, Borrelia Burgdorferi BacterinLeptospira Canicola-Grippotyphosa-Icterohaemorrhagiae-Pomona Bacterial

Extract

47E5.21 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Canine Coronavirus Vaccine, Killed Virus, Leptospira Canicola-GrippotyphosaIcterohaemorrhagiae-Pomona Bacterial Extract46E5.27 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Canine Distemper-Adenovirus Type 2-Coronavirus-Parainfluenza-Parvovirus

Vaccine, Modified Live & Killed Virus, Borrelia Burgdorferi Bacterin

47C5.29 Elanco US Inc./Est No. 196

Canine Distemper-Adenovirus Type 2-Coronavirus-Parainfluenza-Parvovirus

Vaccine, Modified Live & Killed Virus, Borrelia Burgdorferi BacterinLeptospira Canicola-Grippotyphosa-Icterohaemorrhagiae-Pomona Bacterial

Extract

46B9.21 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Canine Distemper-Adenovirus Type 2-Coronavirus-Parainfluenza-Parvovirus

Vaccine, Modified Live & Killed Virus, Leptospira Icterohaemorrhagiae

Bacterial Extract

46L9.27 Elanco US Inc./Est No. 196

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

Modified Live & Killed Virus

1599.27 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

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

Modified Live & Killed Virus, Leptospira Canicola-GrippotyphosaIcterohaemorrhagiae-Pomona Bacterial Extract

45J9.20 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

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

Modified Live & Killed Virus, Leptospira Icterohaemorrhagiae Bacterial Extract

46P9.27 Elanco US Inc./Est No. 196

Canine Distemper-Adenovirus Type 2-Parainfluenza Vaccine, Modified Live

Virus

13C1.20 Elanco US Inc./Est No. 196

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

Modified Live Virus, Borrelia Burgdorferi Bacterin-Leptospira CanicolaGrippotyphosa-Icterohaemorrhagiae-Pomona Bacterial Extract

46D9.20 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Canine Ehrlichia Antibody Test Kit 5039.20 Abaxis, Inc./Est No. 424

Canine Parainfluenza-Bordetella Bronchiseptica Vaccine, Modified Live Virus,

Avirulent Live Culture

14M1.20 Elanco US Inc./Est No. 196

Canine Parvovirus Vaccine, Modified Live Virus, Leptospira Canicola

Icterohaemorrhagiae Bacterin

47B1.20 Elanco US Inc./Est No. 196

Chlamydia Psittaci Vaccine, Killed Chlamydia 1585.20 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Encephalomyelitis Vaccine, Eastern & Western & Venezuelan, Killed Virus,

Tetanus Toxoid

4867.22 Zoetis Inc./Est No. 190

An Equal Opportunity Provider and Employer
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 20-03

Page 3

________________________________________________________________

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

follows:

True Name Code Est. Name/No.

Encephalomyelitis-Influenza Vaccine, Eastern & Western & Venezuelan, Killed

Virus, Tetanus Toxoid

4875.26 Zoetis Inc./Est No. 190

Encephalomyelitis-West Nile Virus Vaccine, Eastern & Western, Killed Virus,

Killed Flavivirus Chimera

14W5.R1 Intervet Inc./Est No. 165A

Equine Rhinopneumonitis Vaccine, Modified Live Virus 1521.21 Elanco US Inc./Est No. 196

Feline Leukemia Vaccine, Killed Virus 1555.R1 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Feline Leukemia Vaccine, Killed Virus 1555.R5 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Feline Leukemia-Rhinotracheitis-Calici-Panleukopenia Vaccine, Killed Virus 15B5.22 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Feline Leukemia-Rhinotracheitis-Calici-Panleukopenia Vaccine, Modified Live

& Killed Virus

15B9.21 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Feline Leukemia-Rhinotracheitis-Calici-Panleukopenia-Chlamydia Psittaci

Vaccine, Killed Virus, Killed Chlamydia

1559.23 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Feline Rhinotracheitis-Calici-Panleukopenia Vaccine, Killed Virus 16D5.22 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Feline Rhinotracheitis-Calici-Panleukopenia Vaccine, Killed Virus 16D5.23 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Feline Rhinotracheitis-Calici-Panleukopenia Vaccine, Modified Live Virus 16D8.20 Elanco US Inc./Est No. 196

Feline Rhinotracheitis-Calici-Panleukopenia-Chlamydia Psittaci Vaccine, Killed

Virus, Killed Chlamydia

16E5.23 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Feline Rhinotracheitis-Calici-Panleukopenia-Chlamydia Psittaci Vaccine,

Modified Live Virus, Killed Chlamydia

16E6.20 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Heartworm Antigen Test Kit 5018.00 Abaxis, Inc./Est No. 424

Mannheimia Haemolytica Toxoid 8699.01 Elanco US Inc./Est No. 196

Mycobacterium Avium subspecies Paratuberculosis Bacterin 2773.00 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Mycobacterium Avium subspecies Paratuberculosis Bacterin 2773.00 Elanco US Inc./Est No. 196

Newcastle Disease Vaccine, Killed Virus 1705.11 Elanco US Inc./Est No. 196

Newcastle-Bronchitis Vaccine, B1 Type, B1 Strain, Mass & Ark Types, Live

Virus

17A1.1M Zoetis Inc./Est No. 190

Newcastle-Bronchitis Vaccine, B1 Type, LaSota Strain, Mass & Conn Types,

Live Virus

1771.17 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Parvovirus Vaccine, Killed Virus 18P5.22 Zoetis Inc./Est No. 190

Parvovirus Vaccine, Killed Virus A8P5.23 Zoetis Inc./Est No. 190

Parvovirus Vaccine, Modified Live Virus 18M1.29 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Parvovirus Vaccine, Modified Live Virus 18M1.21 Elanco US Inc./Est No. 196

Rabies Vaccine, Killed Virus 1905.24 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Rabies Vaccine, Live Raccoon Poxvirus Vector 1901.R5 Elanco US Inc./Est No. 196

Trichomonas Foetus Vaccine, Killed Protozoa 1859.00 Elanco US Inc./Est No. 196

Trichomonas Foetus Vaccine, Killed Protozoa-Campylobacter Fetus-Leptospira

Canicola-Grippotyphosa-Hardjo-Icterohaemorrhagiae-Pomona Bacterin

4990.00 Elanco US Inc./Est No. 196

Previous Est.

No./Prod Code

True Name Code Purchasing Est. Name/No.

From Firm 424 -

Code 575120

Canine Anaplasma Antibody Test Kit 5751.20 Zoetis Inc./Est No. 190

From Firm 424 -

Code 501750

Canine Borrelia Burgdorferi Antibody Test Kit 5017.50 Zoetis Inc./Est No. 190

From Firm 424 -

Code 503920

Canine Ehrlichia Antibody Test Kit 5039.20 Zoetis Inc./Est No. 190

From Firm 424 -

Code 501800

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

An Equal Opportunity Provider and Employer