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:

________________________________________________________________

U.S. Veterinary Biologics Establishment Licenses and Permits (Permittees) 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. 19-01

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, 2018 and December 31, 2018. These do not include those licenses

reissued to update pertinent information.

Est. Name and Address Est. No. Type

IDT Biologika Corporation

Rockville, MD

482A Permittee

True Name Code Est. Name/No.

Bovine Coronavirus-Escherichia Coli Antibody, Bovine Origin 36B5.02 ImmuCell Corporation/Est No. 327

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

Marek's Disease Vector

1A89.R1 Intervet Inc./Est No. 165A

Equine Rhinopneumonitis Vaccine, Modified Live Virus A521.21 Merial, Inc./Est No. 298

Equine Rhinopneumonitis Vaccine, Modified Live Virus 1521.22 Boehringer Ingelheim Vetmedica,

Inc./Est No. 124

Equine Rhinopneumonitis Virus, Modified Live Virus A521.20 Boehringer Ingelheim Vetmedica,

Inc./Est No. 124

Giardia Antigen Test Kit 5G05.52 Safepath Laboratories/Est No. 430

Mycobacterium Paratuberculosis Antibody Test Kit 5064.20 VMRD, Inc./Est No. 332

Est. Name and Address Est. No. Type

Antelope Valley Bios, Inc.

Lincoln, NE

419 Licensee

Transboundary Animal Biologics, Inc.

Ames, IA

428B Permittee

An Equal Opportunity Provider and Employer
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 19-01

Page 2

U.S. Veterinary Biological Product Licenses and Permits (codes) were terminated without prejudice

as follows:

________________________________________________________________

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

follows:

True Name Code Est. Name/No.

Autogenous Bacterin 2051.01 Antelope Valley Bios, Inc./Est No. 419

Autogenous Vaccine, Killed Virus 1015.20 Antelope Valley Bios, Inc./Est No. 419

Autogenous Vaccine, Killed Virus, Autogenous Bacterin 4500.20 Antelope Valley Bios, Inc./Est No. 419

Avian Influenza Vaccine, H5 Subtype, DNA 1057.D0 Antelope Valley Bios, Inc./Est No. 419

Avian Polyomavirus Vaccine, Killed Virus 1A15.00 Antelope Valley Bios, Inc./Est No. 419

Bursal Disease Vaccine, Live Virus 1271.11 Elanco US Inc./Est No. 196

Canine Osteosarcoma Vaccine, Live Listeria Vector 9243.R0 Antelope Valley Bios, Inc./Est No. 419

Encephalomyelitis Vaccine, Eastern & Western, Killed Virus 1475.00 Merial, Inc./Est No. 298

Encephalomyelitis Vaccine, Eastern & Western, Killed Virus, Tetanus Toxoid 4865.00 Merial, Inc./Est No. 298

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

Live Canarypox Vector

14W7.R0 Merial, Inc./Est No. 298

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

Live Canarypox Vector, Tetanus Toxoid

48W9.R0 Merial, Inc./Est No. 298

Equine Influenza Vaccine, Live Canarypox Vector 1501.R0 Merial, Inc./Est No. 298

Escherichia Coli Bacterin-Toxoid 7900.R0 Zoetis Inc./Est No. 190

Feline Leukemia Vaccine, Live Canarypox Vector 1555.R3 Merial, Inc./Est No. 298

Marek's Disease Vaccine, Serotype 3, Live Virus 1641.01 Merial, Inc./Est No. 298

Mycoplasma Hyopneumoniae Bacterin 2775.02 Merial, Inc./Est No. 298

Mycoplasma Hyopneumoniae Bacterin 2775.03 Merial, Inc./Est No. 298

Mycoplasma Hyopneumoniae Bacterin 2775.04 Merial, Inc./Est No. 298

Newcastle Disease Vaccine, B1 Type, B1 Strain, Live Virus 1711.10 Elanco US Inc./Est No. 196

Newcastle Disease Vaccine, VG/GA Strain, Live Virus 17A2.V1 Merial, Inc./Est No. 298

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

Live Virus

1771.14 Merial, Inc./Est No. 298

Newcastle-Bronchitis Vaccine, VG/GA Strain, Mass & Conn Types, Live Virus 17V1.11 Merial, Inc./Est No. 298

Porcine Circovirus Vaccine, Type 2, Killed Virus 19K5.20 Merial, Inc./Est No. 298

Porcine Circovirus Vaccine, Type 2, Killed Virus, Mycoplasma Hyopneumoniae

Bacterin

48K5.20 Merial, Inc./Est No. 298

Porcine Reproductive & Respiratory Syndrome Vaccine, Respiratory Form,

Modified Live Virus

19S1.20 Boehringer Ingelheim Vetmedica,

Inc./Est No. 124

Porcine Reproductive & Respiratory Syndrome Vaccine, Respiratory Form,

Modified Live Virus

19S1.R2 Merial, Inc./Est No. 298

Tetanus Toxoid 8601.00 Merial, Inc./Est No. 298

West Nile Virus Vaccine, Killed Virus 1995.22 Zoetis Inc./Est No. 190

West Nile Virus Vaccine, Live Canarypox Vector 1991.R0 Merial, Inc./Est No. 298

Previous Est.

No./Prod Code

True Name Code Purchasing Est. Name/No.

From Firm 419 -

Code 205101, first

licensed 05/02/2008

Autogenous Bacterin 2051.01 Huvepharma, Inc./Est No. 605

From Firm 419 -

Code 101520, first

licensed 08/16/2016

Autogenous Vaccine, Killed Virus 1015.20 Huvepharma, Inc./Est No. 605

From Firm 419 -

Code 450020, first

licensed 11/01/2016

Autogenous Vaccine, Killed Virus, Autogenous Bacterin 4500.20 Huvepharma, Inc./Est No. 605

From Firm 419 -

Code 1057D0, first

licensed 11/07/2017

Avian Influenza Vaccine, H5 Subtype, DNA 1057.D0 Huvepharma, Inc./Est No. 605

An Equal Opportunity Provider and Employer
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 19-01

Page 3

Previous Est.

No./Prod Code

True Name Code Purchasing Est. Name/No.

From Firm 419 -

Code 1A1500, first

licensed 04/28/2014

Avian Polyomavirus Vaccine, Killed Virus 1A15.00 Huvepharma, Inc./Est No. 605

From Firm 419 -

Code 9243R0, first

licensed 12/19/2017

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

An Equal Opportunity Provider and Employer