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. 19-06

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, 2019 and June 30, 2019. These do not include those licenses

reissued to update pertinent information.

True Name Code Est. Name/No.

Autogenous Killed Culture B051.00 Medgene Labs/Est No. 474

Autogenous Vaccine, Killed Virus, Autogenous Bacterin 4500.20 Diamond Animal Health, Inc./Est No.

213

Avian Influenza Virus, H5 Subtype, Killed Baculovirus Vector A057.R1 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Lawsonia Intracellularis Vaccine, Avirulent Live Culture 10L1.20 ARKO Laboratories, Ltd./Est No. 337

Porcine Circovirus Vaccine, Type 2, Killed Baculovirus Vector, Mycoplasma

Hyopneumoniae Bacterin

D9K5.R0 Pharmgate Biologics, Inc./Est No. 329

Porcine Circovirus, Type 2, Killed Baculovirus Vector A9K5.R0 Pharmgate Biologics, Inc./Est No. 329

Porcine Reproductive & Respiratory Syndrome Vaccine, Respiratory Form,

Modified Live Virus

19S1.R0 Pharmgate Biologics, Inc./Est No. 329

True Name Code Est. Name/No.

Autogenous Virus, Live Virus A015.11 Charles River Laboratories, Inc./Est No.

344

Bovine IgG 3606.00 Sera, Inc./Est No. 328

An Equal Opportunity Provider and Employer
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 19-06

Page 2

________________________________________________________________

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

True Name Code Est. Name/No.

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

Killed Virus

12M5.43 Elanco US Inc./Est No. 196

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

Modified Live Virus, Leptospira Canicola-Icterohaemorrhagiae Bacterin

46J8.20 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Canine Parainfluenza Virus, Modified Live Virus A421.21 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Canine Parvovirus Vaccine, Modified Live Virus, Leptospira Canicola

Icterohaemorrhagiae Bacterin

47B1.20 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Coccidiosis Vaccine, Live Oocysts 1431.50 Biomune Company/Est No. 368A

Equine IgG C607.00 Sera, Inc./Est No. 328

Equine Rhinopneumonitis Virus, Modified Live Virus A521.20 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Erysipelothrix Rhusiopathiae Bacterin 2641.03 Zoetis Inc./Est No. 190

Erysipelothrix Rhusiopathiae-Haemophilus Parasuis Bacterin 2646.01 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Feline Leukemia-Chlamydia Psittaci Vaccine, Killed Virus, Killed Chlamydia 1A69.20 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Feline Leukemia-Rhinotracheitis-Calici-Panleukopenia-Chlamydia Psittaci

Vaccine, Modified Live & Killed Virus, Killed Chlamydia

1559.2C Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Feline Rhinotracheitis-Calici-Panleukopenia Vaccine, Modified Live Virus 16D8.20 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Mannheimia Haemolytica-Pasteurella Multocida Bacterin-Toxoid 7935.02 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Marek's Disease Vaccine, Serotype 3, Live Virus 1641.03 Zoetis Inc./Est No. 190

Moraxella Bovoculi Bacterin 2A77.01 Addison Biological Laboratory, Inc./Est

No. 355

Mycoplasma Hyopneumoniae Bacterin 2775.01 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Mycoplasma Synoviae Bacterin 2776.00 Zoetis Inc./Est No. 190

Pigeon Pox Vaccine, Live Virus 1881.12 Elanco US Inc./Est No. 196

Pigeon Pox Vaccine, Live Virus 1881.10 Elanco US Inc./Est No. 196

An Equal Opportunity Provider and Employer