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:

________________________________________________________________

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. 20-04

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, 2020 and June 30, 2020. These do not include those licenses

reissued to update pertinent information.

True Name Code Est. Name/No.

Bovine Rhinotracheitis-Virus Diarrhea Vaccine, Modified Live Virus,

Mannheimia Haemolytica Bacterial Extract-Toxoid

4X29.R0 Elanco US Inc./Est No. 196

Bovine Virus Diarrhea Vaccine, Modified Live Virus, Mannheimia Haemolytica

Bacterial Extract-Toxoid

4X39.R0 Elanco US Inc./Est No. 196

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

Marek's Disease Vector

1A89.R1 Biomune Company/Est No. 368

Bursal Disease-Marek's Disease-Newcastle Disease Vaccine, Serotypes 2 & 3,

Live Virus, Live Marek's Disease Vector

1A91.R2 Biomune Company/Est No. 368

Canine Coronavirus Vaccine, Killed Virus 14P5.21 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Canine Coronavirus Vaccine, Killed Virus, Leptospira Canicola-GrippotyphosaIcterohaemorrhagiae-Pomona Bacterial Extract46E5.28 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

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

Vaccine, Modified Live & Killed Virus

1599.24 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

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

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

46J9.23 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

46P9.21 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

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

Modified Live Virus

13D1.24 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Canine Distemper-Adenovirus Type 2-Parvovirus Vaccine, Modified Live Virus 1331.22 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Clostridium Chauvoei, Killed Culture B250.00 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Lawsonia Intracellularis Bacterin 2799.21 Intervet Inc./Est No. 165A

An Equal Opportunity Provider and Employer
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 20-04

Page 2

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.

Est. Name and Address Est. No. Type

Thermo Fisher Scientific

Austin, TX

582A Permittee

True Name Code Est. Name/No.

Allergenic Extract, Prescription Product 9531.00 ALK-Abello, Inc./Est No. 259

Bordetella Bronchiseptica Bacterin 2100.00 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Bovine Rhinotracheitis-Virus Diarrhea-Parainfluenza 3-Respiratory Syncytial

Virus Vaccine, Killed Virus, Haemophilus Somnus-Leptospira CanicolaGrippotyphosa-Hardjo-Icterohaemorrhagiae-Pomona Bacterin

44D7.20 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Bovine Rhinotracheitis-Virus Diarrhea-Parainfluenza 3-Respiratory Syncytial

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

4465.20 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Bursal Disease-Newcastle Disease-Bronchitis-Reovirus Vaccine, Mass Type,

Killed Virus

12M5.91 Zoetis Inc./Est No. 190

Canine Coronavirus Vaccine, Killed Virus, Borrelia Burgdorferi Bacterin 47A5.20 Elanco US Inc./Est No. 196

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

Vaccine, Modified Live & Killed Virus, Leptospira Icterohaemorrhagiae

Bacterial Extract

46L9.20 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

46P9.20 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Canine Parainfluenza Vaccine, Modified Live Virus 1421.20 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Canine Parainfluenza Vaccine, Modified Live Virus, Bordetella Bronchiseptica

Bacterin

47A1.20 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

An Equal Opportunity Provider and Employer