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. 21-08

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, 2021 and September 30, 2021. These do not include those licenses

reissued to update pertinent information.

True Name Code Est. Name/No.

Autogenous Virus, Killed Virus A015.20 Diamond Animal Health, Inc./Est No.

213

Bursal Disease-Marek's Disease-Newcastle Disease Vaccine, Serotypes 1 & 3,

Live Virus, Live Marek's Disease Vector

1A91.R1 Ceva Animal Health, LLC/Est No. 368

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

Virus, Killed Chlamydia

16E5.22 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Mycoplasma Bovis Vaccine, Avirulent Live Culture 1750.U0 Zoetis Inc./Est No. 190

Porcine Circovirus, Type 1 - Type 2 Chimera, Killed Virus A9K5.R3 Zoetis Inc./Est No. 190

Prescription Product, Killed Baculovirus Vector 9PP0.R0 Medgene Labs/Est No. 474

Swine Influenza Vaccine, H3, Killed Baculovirus Vector 19A5.R9 Medgene Labs/Est No. 474

True Name Code Est. Name/No.

Autogenous Bacterin 2051.00 Pharmgate Biologics, Inc./Est No. 329

Autogenous Killed Culture B051.00 Pharmgate Biologics, Inc./Est No. 329

Bordetella Avium, Avirulent Live Culture A021.01 Intervet Inc./Est No. 165A

Bordetella Bronchiseptica Bacterin 2100.00 Elanco US Inc./Est No. 196

An Equal Opportunity Provider and Employer
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 21-07

Page 2

True Name Code Est. Name/No.

Bovine Parainfluenza 3 Virus, Modified Live Virus A841.22 Zoetis Inc./Est No. 190

Bovine Respiratory Syncytial Virus Vaccine, Modified Live Virus 1091.20 Zoetis Inc./Est No. 190

Bovine Rhinotracheitis-Virus Diarrhea Vaccine, Modified Live Virus 1151.22 Intervet Inc./Est No. 165A

Bovine Rhinotracheitis-Virus Diarrhea Vaccine, Modified Live Virus,

Campylobacter Fetus-Leptospira Canicola-Grippotyphosa-HardjoIcterohaemorrhagiae-Pomona Bacterin

4141.20 Intervet Inc./Est No. 165A

Bovine Rhinotracheitis-Virus Diarrhea-Parainfluenza 3-Respiratory Syncytial

Virus Vaccine, Killed Virus

1185.20 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Bovine Rhinotracheitis-Virus Diarrhea-Parainfluenza 3-Respiratory Syncytial

Virus Vaccine, Killed Virus, Haemophilus Somnus Bacterin

44D5.20 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Bovine Rhinotracheitis-Virus Diarrhea-Parainfluenza 3-Respiratory Syncytial

Virus Vaccine, Modified Live Virus, Leptospira Hardjo Bacterin

4L49.20 Zoetis Inc./Est No. 190

Bronchitis Vaccine, Georgia Type, Live Virus 1231.1J Intervet Inc./Est No. 165A

Bursal Disease Vaccine, Live Virus 1271.40 Intervet Inc./Est No. 165A

Bursal Disease Virus, Live Virus A271.21 Intervet Inc./Est No. 165A

Canine Distemper Vaccine, Modified Live Virus 1301.20 Intervet Inc./Est No. 165A

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

Vaccine, Modified Live & Killed Virus

1599.29 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

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

Modified Live Virus

13D1.21 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

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

Modified Live Virus

13D1.24 Intervet Inc./Est No. 165A

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

Modified Live Virus, Leptospira Canicola-Grippotyphosa-IcterohaemorrhagiaePomona Bacterial Extract

4637.29 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Canine Parainfluenza Vaccine, Modified Live Virus 1421.20 Elanco US Inc./Est No. 196

Canine Parainfluenza Vaccine, Modified Live Virus, Bordetella Bronchiseptica

Bacterin

47A1.20 Elanco US Inc./Est No. 196

Canine Parainfluenza-Bordetella Bronchiseptica Vaccine, Modified Live Virus,

Avirulent Live Culture

14M1.20 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Clostridium Perfringens Type A Toxoid 8081.00 Elanco US Inc./Est No. 196

Clostridium Perfringens Type A Toxoid 8081.01 Elanco US Inc./Est No. 196

Clostridium Perfringens Type C-Escherichia Coli Bacterin-Toxoid 7890.00 Intervet Inc./Est No. 165A

Clostridium Perfringens Types C & D Antitoxin, Equine Origin 6221.00 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Coccidiosis Vaccine, Live Oocysts 1431.5C Intervet Inc./Est No. 165A

Equine Rhinopneumonitis Vaccine, Modified Live Virus 1521.21 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Erysipelothrix Rhusiopathiae Bacterin 2641.02 Intervet Inc./Est No. 165A

Erysipelothrix Rhusiopathiae Bacterin 2641.01 Intervet Inc./Est No. 165A

Erysipelothrix Rhusiopathiae-Mycoplasma Hyopneumoniae Bacterin 2A41.01 Intervet Inc./Est No. 165A

Erysipelothrix Rhusiopathiae-Mycoplasma Hyopneumoniae Bacterin 2A41.00 Intervet Inc./Est No. 165A

Escherichia Coli Antibody, Equine Origin 3526.00 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Escherichia Coli Bacterin 2648.43 Intervet Inc./Est No. 165A

Feline Rhinotracheitis-Calici-Panleukopenia Vaccine, Modified Live & Killed

Virus

16D9.20 Intervet Inc./Est No. 165A

Feline Rhinotracheitis-Calici-Panleukopenia Vaccine, Modified Live Virus 16D1.22 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Feline Rhinotracheitis-Calicivirus Vaccine, Modified Live Virus 16C1.20 Intervet Inc./Est No. 165A

Fowl Laryngotracheitis Vaccine, Modified Live Virus 1601.02 Intervet Inc./Est No. 165A

Glaesserella Parasuis Bacterin 2652.00 Intervet Inc./Est No. 165A

Glaesserella Parasuis-Mycoplasma Hyopneumoniae Bacterin 2565.00 Intervet Inc./Est No. 165A

Mannheimia Haemolytica-Pasteurella Multocida Vaccine, Avirulent Live Culture 1861.R0 Intervet Inc./Est No. 165A

Marek's Disease Vaccine, Serotypes 1 & 3, Live Herpesvirus Chimera 1631.R0 Intervet Inc./Est No. 165A

Moraxella Bovis Bacterin 2772.04 Intervet Inc./Est No. 165A

Mycobacterium Cell Wall Fraction I300.00 NovaVive USA Inc./Est No. 289

Mycoplasma Hyopneumoniae Bacterin 2775.05 Pharmgate Biologics, Inc./Est No. 329

Mycoplasma Hyopneumoniae Bacterin 2775.02 Pharmgate Biologics, Inc./Est No. 329

Parvovirus Vaccine, Modified Live Virus 18M1.21 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Parvovirus-Swine Influenza Vaccine, H1N1 & H1N2 & H3N2, Killed Virus,

Erysipelothrix Rhusiopathiae-Leptospira Bratislava-Canicola-GrippotyphosaHardjo-Icterohaemorrhagiae-Pomona Bacterin

49F6.2A Zoetis Inc./Est No. 190

Parvovirus-Swine Influenza Vaccine, H1N1 & H1N2 & H3N2, Killed Virus,

Erysipelothrix Rhusiopathiae-Leptospira Canicola-Grippotyphosa-HardjoIcterohaemorrhagiae-Pomona Bacterin

49G6.2A Zoetis Inc./Est No. 190

An Equal Opportunity Provider and Employer
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 21-07

Page 3

________________________________________________________________

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

follows:

True Name Code Est. Name/No.

Pigeon Pox Vaccine, Live Virus 1881.14 Intervet Inc./Est No. 165A

Swine Influenza Vaccine, H1N1 & H1N2 & H3N2, Killed Virus 19A5.2A Zoetis Inc./Est No. 190

Swine Influenza Vaccine, H1N1 & H1N2 & H3N2, Killed Virus, Erysipelothrix

Rhusiopathiae-Mycoplasma Hyopneumoniae Bacterin

4994.2B Zoetis Inc./Est No. 190

Swine Influenza Vaccine, H1N1 & H1N2 & H3N2, Killed Virus, Mycoplasma

Hyopneumoniae Bacterin

4995.2A Zoetis Inc./Est No. 190

Swine Influenza Vaccine, H1N1 & H1N2 & H3N2, Killed Virus, Mycoplasma

Hyopneumoniae Bacterin

4995.2B Zoetis Inc./Est No. 190

Swine Influenza Vaccine, H1N1 & H3N2, Killed Virus 19A5.24 Intervet Inc./Est No. 165A

Swine Influenza Vaccine, H1N1 & H3N2, Killed Virus, Mycoplasma

Hyopneumoniae Bacterin

4995.23 Zoetis Inc./Est No. 190

Swine Influenza Vaccine, RNA 19A5.D0 Intervet Inc./Est No. 165A

Trueperella Pyogenes-Escherichia Coli-Pasteurella Multocida-Salmonella

Typhimurium Antibody, Bovine Origin

3400.00 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Previous Est.

No./Prod Code

True Name Code Purchasing Est. Name/No.

From Firm 124 -

Code 155920, first

licensed 04/04/2011

Feline Leukemia-Rhinotracheitis-Calici-PanleukopeniaChlamydia Psittaci Vaccine, Killed Virus, Killed Chlamydia1559.22 Boehringer Ingelheim Animal

Health USA Inc./Est No. 124

From Firm 124 -

Code 16D520, first

licensed 04/04/2011

Feline Rhinotracheitis-Calici-Panleukopenia Vaccine, Killed

Virus

16D5.21 Boehringer Ingelheim Animal

Health USA Inc./Est No. 124

An Equal Opportunity Provider and Employer