Animal & Veterinary

Designations List

DESIGNATION IS A STATUS THAT MAKES A PHARMACEUTICAL SPONSOR ELIGIBLE FOR INCENTIVES TO SUPPORT DRUG APPROVAL. DESIGNATION DOES NOT ALLOW THE DRUG TO BE MARKETED (SOLD, PROMOTED, OR ADVERTISED).  IT IS ILLEGAL TO MARKET THESE PRODUCTS UNTIL THEY ARE APPROVED OR CONDITIONALLY APPROVED. (See the “Status” column of this table for approval information).

No. Sponsor Name & Address Established &
Proprietary Name
Dosage Form Species Intended Use
(Indication + species)
Designation Modified Status
1 Intervet, Inc. (d/b/a Merck Animal Health)
556 Morris Avenue
Summit, NJ 07901
Florfenicol
AQUAFLOR
Type A medicated feed Catfish For the control of mortality in catfish due to enteric septicemia of catfish associated with Edwardsiella ictaluri 8/18/2005   NADA 141-246 approved 10/24/2005
Exclusive marketing rights expired 10/24/2012
 
2 Intervet, Inc. (d/b/a Merck Animal Health)
556 Morris Avenue
Summit, NJ 07901
Florfenicol
AQUAFLOR
 
Type A medicated feed Freshwater-reared warmwater finfish For the control of mortality in freshwater-reared warmwater finfish due to streptococcal septicemia associated with Streptococcus iniae 9/19/2005 5/28/2010 NADA 141-246
approved 4/4/2012
 
3 Intervet, Inc. (d/b/a Merck Animal Health)
556 Morris Avenue
Summit, NJ 07901
Florfenicol
AQUAFLOR
 
Type A medicated feed Freshwater-reared salmonids For the control of mortality in freshwater reared salmonids due to coldwater disease associated with Flavobacterium psychrophilum 9/19/2005 9/6/2006 NADA 141-246 approved 3/19/2007
Exclusive marketing rights expired 3/19/2014
 
4 Intervet, Inc. (d/b/a Merck Animal Health)
556 Morris Avenue
Summit, NJ 07901
Florfenicol
AQUAFLOR
 
Type A medicated feed Freshwater-reared salmonids For the control of mortality in freshwater reared salmonids due to columnaris disease associated with Flavobacterium columnare 9/19/2005 9/6/2006 Designation terminated at sponsor's request 9/30/2011
5 Intervet, Inc. (d/b/a Merck Animal Health)
556 Morris Avenue
Summit, NJ 07901
Florfenicol
AQUAFLOR
 
Type A medicated feed Freshwater-reared salmonids For the control of mortality in freshwater reared salmonids due to furunculosis associated with Aeromonas salmonicida 9/19/2005 9/6/2006 NADA 141-246 approved 10/26/2007
Exclusive marketing rights expired 10/26/2014
 
6 Intervet, Inc. (d/b/a Merck Animal Health)
556 Morris Avenue
Summit, NJ 07901
Florfenicol
AQUAFLOR
 
Type A medicated feed Freshwater-reared salmonids For the control of mortality in freshwater reared salmonids due to enteric redmouth disease associated with Yersinia ruckeri 9/19/2005 9/6/2006  
7 Intervet, Inc. (d/b/a Merck Animal Health)
556 Morris Avenue
Summit, NJ 07901
Florfenicol
AQUAFLOR
 
Type A medicated feed Tilapia For the control of mortality in tilapia due to streptococcal septicemia associated with Streptococcus iniae 9/19/2005 1/9/2007 Designation terminated at sponsor's request 5/28/2010
8 Intervet, Inc. (d/b/a Merck Animal Health)
556 Morris Avenue
Summit, NJ 07901
Florfenicol
AQUAFLOR
 
Type A medicated feed Freshwater-reared warmwater finfish For the control of mortality in freshwater-reared warmwater finfish due to hemorrhagic septicemia associated with Aeromonas hydrophila 9/19/2005 5/28/2010  
9 Intervet, Inc. (d/b/a Merck Animal Health)
556 Morris Avenue
Summit, NJ 07901
Florfenicol
AQUAFLOR
Type A medicated feed Tilapia For the control of mortality in tilapia due to edwardsiellosis associated with Edwardsiella tarda 9/19/2005 1/9/2007  
10 Intervet, Inc. (d/b/a Merck Animal Health)
556 Morris Avenue
Summit, NJ 07901
Florfenicol
AQUAFLOR
 
Type A medicated feed Seawater-reared salmonids For the control of mortality in seawater-reared salmonids due to furunculosis associated with Aeromonas salmonicida 9/19/2005 1/11/2007 Designation terminated at sponsor's request 7/25/2013
11 Intervet, Inc. (d/b/a Merck Animal Health)
556 Morris Avenue
Summit, NJ 07901
Florfenicol
AQUAFLOR
 
Type A medicated feed Seawater-reared salmonids For the control of mortality in seawater-reared salmonids due to cold-water vibriosis associated with Vibrio salmonicida 9/19/2005 1/11/2007 Designation terminated at sponsor's request 7/25/2013
12 Boehringer Ingelheim Vetmedica, Inc.
2621 North Belt Highway
St. Joseph, MO 64506
Moxidectin
CYDECTIN
Oral Sheep For the treatment and control of adult and larval (L4) stages of the following internal parasites of sheep: Haemonchus contortus, Teladorsagia circumcincta, Teladorsagia trifurcata, Trichostrongylus axei, Trichostrongylus colubriformis, Trichostrongylus vitrinus, Cooperia curticei, Cooperia oncophora, Oesophagostomum columbianum, Oesophagostomum venulosum, Nematodirus battus, Nematodirus filicollis, Nematordirus spathige 10/14/2005   NADA 141-247 approved 11/30/2005
Exclusive marketing rights expired 11/30/2012
 
13 Western Chemical, Inc.
1269 Lattimore Road
Ferndale, WA 98248
Hydrogen peroxide
35% PEROX-AID
Immersion Freshwater-reared finfish eggs For the control of mortality in freshwater-reared finfish eggs due to saprolegniasis 12/1/2005   NADA 141-255 approved 1/11/2007
Exclusive marketing rights expired 1/11/2014
 
14 Western Chemical, Inc.
1269 Lattimore Road
Ferndale, WA 98248
Hydrogen peroxide
35% PEROX-AID
Immersion Freshwater-reared salmonids For the control of mortality in freshwater-reared salmonids due to bacterial gill disease associated with Flavobacterium branchiophilum 12/1/2005   NADA 141-255 approved 1/11/2007
Exclusive marketing rights expired 1/11/2014
 
15 Western Chemical, Inc.
1269 Lattimore Road
Ferndale, WA 98248
Hydrogen peroxide
35% PEROX-AID
Immersion Freshwater-reared coolwater finfish and channel catfish For the control of mortality in freshwater-reared coolwater finfish and channel catfish due to external columnaris disease associated with Flavobacterium columnare 12/1/2005   NADA 141-255 approved 1/11/2007
Exclusive marketing rights expired 1/11/2014
 
16 Zoetis Inc.
333 Portage Street
Kalamazoo, MI 49007
Progesterone
EAZI-BREED CIDR Sheep Insert
Intravaginal Sheep For the induction of estrus in ewes (sheep) during seasonal anestrous 12/14/2005   NADA 141-302 approved 10/1/2009
17 Western Chemical, Inc.
1269 Lattimore Road
Ferndale, WA 98248
Hydrogen peroxide
35% PEROX-AID
Immersion Freshwater-reared finfish For the control of mortality in freshwater-reared finfish (except freshwater-reared coolwater finfish and warmwater finfish) due to external columnaris disease associated with Flavobacterium columnare 12/20/2005 5/22/2015  
18 Western Chemical, Inc.
1269 Lattimore Road
Ferndale, WA 98248
Hydrogen peroxide
35% PEROX-AID
Immersion Freshwater-reared finfish For the control of mortality in freshwater-reared finfish due to saprolegniasis associated with fungi in the family Saprolegniaceae 12/20/2005 5/22/2015  
19 Western Chemical, Inc.
1269 Lattimore Road
Ferndale, WA 98248
Calcein
SE-MARK
Immersion Freshwater-reared finfish fry & fingerlings For the skeletal marking of freshwater-reared finfish fry and fingerlings 1/26/2006   Designation terminated at sponsor's request 8/25/2011
20 Rangen, Inc.
115 13th Avenue South
Buhl, ID 83316
17a-methyl testosterone
MASCULINIZING
FEED FOR TILAPIA
Medicated feed Tilapia For the masculinization of female early life-stage tilapia 1/27/2006    
21 AQUI-S New Zealand Ltd
Unit 5, 6 Aglionby Street
P.O. Box 44-269
Lower Hutt, New Zealand
 
Isoeugenol
AQUI-S
Immersion Freshwater-reared finfish To sedate freshwater-reared finfish to handleable 2/6/2006    
22 AQUI-S New Zealand Ltd
Unit 5, 6 Aglionby Street
P.O. Box 44-269
Lower Hutt, New Zealand
 
Isoeugenol
AQUI-S
Immersion Freshwater-reared finfish To anesthetize freshwater-reared finfish 2/6/2006    
23 GB Research, Inc.
(US agent Kent SeaTech Corp.)
11125 Flintkote Avenue, Suite J
San Diego, CA 92121
Amoxicillin trihydrate
USP powder
Type A medicated feed Hybrid Striped Bass & Tilapia For the control of mortality in hybrid striped bass and tilapia due to steptococcosis associated with Streptococcus iniae 2/14/2006   Designation terminated at sponsor's request 12/30/2008
24 Intervet, Inc. (d/b/a Merck Animal Health)
556 Morris Avenue
Summit, NJ 07901
Florfenicol
AQUAFLOR
Type A medicated feed Catfish For the control of mortality in catfish due to columnaris disease associated with Flavobacterium columnare 3/13/2006   NADA 141-259 Conditionally approved 4/13/2007

NADA 141-246
approved 4/4/2012
Exclusive marketing rights expired 4/13/2014
 
25 AQUI-S New Zealand Ltd
Unit 5, 6 Aglionby Street
P.O. Box 44-269
Lower Hutt, New Zealand
 
Isoeugenol
AQUI-S
Immersion Seawater-reared salmonids To sedate seawater-reared salmonids to handleable 3/21/2006    
26 AQUI-S New Zealand Ltd
Unit 5, 6 Aglionby Street
P.O. Box 44-269
Lower Hutt, New Zealand
 
Isoeugenol
AQUI-S
Immersion Seawater-reared salmonids To anesthetize seawater-reared salmonids 3/21/2006    
27 Zoetis Inc.
333 Portage Street
Kalamazoo, MI 49007
Albendazole
VALBAZEN
Oral Goats For the treatment of adult liver flukes (Fasciola hepatica) in nonlactating goats 3/24/2006   NADA 110-048 approved 1/24/2008
Exclusive marketing rights expired 1/24/2015
 
28 Phibro Animal Health
Glenpointe Centre East, 3rd Fl.
300 Frank W. Burr Boulevard
Suite 21
Teaneck, NJ 07666
Oxytetracycline
TERRAMYCIN 200 for Fish
Type A medicated feed Freshwater-reared finfish (except steelhead trout) For the control of mortality in freshwater-reared finfish (except Oncorhynchus mykiss) due to columnaris disease associated with Flavobacterium columnare 4/27/2006 3/20/2008  
29 Phibro Animal Health
Glenpointe Centre East, 3rd Fl.
300 Frank W. Burr Boulevard
Suite 21
Teaneck, NJ 07666
Oxytetracycline
TERRAMYCIN 200 for Fish
Type A medicated feed Steelhead trout For the control of mortality in Oncorhynchus mykiss due to columnaris disease associated with Flavobacterium columnare 4/27/2006 3/20/2008 NADA 038-439 approved 7/6/2008
30 Phibro Animal Health
Glenpointe Centre East, 3rd Fl.
300 Frank W. Burr Boulevard
Suite 21
Teaneck, NJ 07666
Oxytetracycline
TERRAMYCIN 200 for Fish
Type A medicated feed Coolwater and warmwater-reared finfish (except salmonids and catfish) For the control of mortality in coolwater and warmwater-reared finfish (except salmonids and catfish) due to bacterial hemorrhagic septicemia associated with Aeromonas hydrophila 4/27/2006    
31 Phibro Animal Health
Glenpointe Centre East, 3rd Fl.
300 Frank W. Burr Boulevard
Suite 21
Teaneck, NJ 07666
Oxytetracycline
TERRAMYCIN 200 for Fish
Type A medicated feed Penaeid shrimp For the control of mortality in penaeid shrimp due to necrotizing hepatopancreatitis 4/27/2006    
32 Phibro Animal Health
Glenpointe Centre East, 3rd Fl.
300 Frank W. Burr Boulevard
Suite 21
Teaneck, NJ 07666
Oxytetracycline
TERRAMYCIN 200 for Fish
Type A medicated feed Freshwater-reared salmonids For the control of mortality in freshwater-reared salmonids due to coldwater disease associated with Flavobacterium psychrophilum 4/27/2006   NADA 038-439 approved 7/6/2008
33 Axcentive SARL
Akzo-Nobel Services, Inc.
525 West Van Buren Street
Chicago, IL 60607
Chloramine-T
HALAMID AQUA
 
Immersion Freshwater-reared salmonids For the control of mortality in freshwater-reared salmonids due to bacterial gill disease associated with Flavobacterium spp 6/13/2006   NADA 141-423
approved 4/30/2014
 
34 Axcentive SARL
Akzo-Nobel Services, Inc.
525 West Van Buren Street
Chicago, IL 60607
Chloramine-T
HALAMID AQUA
 
Immersion Walleye For the control of mortality in walleye due to external columnaris disease associated with Flavobacterium columnare 6/13/2006   NADA 141-423
approved 4/30/2014
 
35 Axcentive SARL
Akzo-Nobel Services, Inc.
525 West Van Buren Street
Chicago, IL 60607
Chloramine-T
HALAMID AQUA
 
Immersion Freshwater-reared finfish (except walleye) For the control of mortality in all freshwater-reared warmwater finfish due to external columnaris disease associated with Flavobacterium columnare 6/13/2006 1/24/2014 NADA 141-423
approved 4/30/2014
 
36 Western Chemical, Inc.
1269 Lattimore Road
Ferndale, WA 98248
sGnRHa & domperidone
OVAPRIM
Injectable Ornamental fish For the induction of spawning in ornamental fish 7/27/2006   Designation terminated at sponsor's request 12/13/2012
37 Carus Chemical Co.
315 Fifth Street
P.O. Box 599
Peru, IL 61354
Potassium permanganate
CAIROX
Immersion Freshwater-reared finfish For the control of mortality in freshwater-reared finfish due to external columnaris disease associated with Flavobacterium columnare 9/12/2006   Designation terminated at sponsor's request 12/22/2011
38 Carus Chemical Co.
315 Fifth Street
P.O. Box 599
Peru, IL 61354
Potassium permanganate
CAIROX
Immersion Freshwater-reared salmonids For the control of mortality in freshwater-reared salmonids due to bacterial gill disease associated with Flavobacterium branchophilum 9/12/2006   Designation terminated at sponsor's request 12/22/2011
39 Carus Chemical Co.
315 Fifth Street
P.O. Box 599
Peru, IL 61354
Potassium permanganate
CAIROX
Immersion Freshwater-reared salmonids For the control of mortality in freshwater-reared salmonids due to coldwater disease associated with Flavobacterium psychrophilum 9/12/2006   Designation terminated at sponsor's request 12/22/2011
40 Axcentive SARL
Akzo-Nobel Services, Inc.
525 West Van Buren Street
Chicago, IL 60607
Chloramine-T
HALAMID AQUA
Immersion Freshwater-reared finfish (except freshwater-reared salmonids) For the control of mortality in freshwater-reared finfish (except freshwater-reared salmonids) due to bacterial gill disease associated with Flavobacterium spp 9/15/2006   Designation terminated at sponsor's request 1/24/2014
41 Zoetis Inc.
333 Portage Street
Kalamazoo, MI 49007
Progesterone
EAZI-BREED CIDR Goat Insert
Intravaginal Goats For synchronization of estrus in meat and dairy goats during the breeding season 10/3/2006    
42 Freeport-McMoRan Sierrita
P.O. Box 527
Green Valley, AZ 85622
 
Copper Sulfate
TRIANGLE BRAND COPPER SULFATE
Immersion Channel catfish For the treatment of ichthyophthiriasis (Ichthyophthirius multifilis) on channel catfish cultured in earthen ponds 10/30/2006    
43 Western Chemical, Inc.
1269 Lattimore Road
Ferndale, WA 98248
Metomidate
AQUACALM
Immersion Ornamental fish For use as a sedative during transport of ornamental (non-food) finfish 4/21/2009   Designation terminated at sponsor's request 5/14/2013
44 Bimeda, A Division of Cross Vetpharm Group, Ltd.
2836 Dolliver Park Avenue
Lehigh, IA 50557
Erythromycin thiocyanate
AQUAMYCIN 100
Type A medicated feed Freshwater-reared salmonids For the control of mortality in freshwater-reared salmonids due to bacterial kidney disease associated with Renibacterium salmoninarum 1/4/2007    
45 Western Chemical, Inc.
1269 Lattimore Road
Ferndale, WA 98248
salmon Gonadotropin Releasing Hormone analog
OVAPLANT
Implantation Salmonids For the induction of spawning in mature salmonids 5/25/2007    
46 Zoetis Inc.
333 Portage Street
Kalamazoo, MI 49007
Oxytetracycline HCl
TERRAMYCIN 343
Immersion Freshwater-reared coolwater and warmwater finfish fry and fingerlings For control of mortality in fry and fingerlings of all coolwater and warmwater species of freshwater-reared finfish due to external columnaris disease associated with Flavobacterium columnare 6/7/2007   Designation terminated at sponsor's request 5/5/2011
47 Zoetis Inc.
333 Portage Street
Kalamazoo, MI 49007
Oxytetracycline HCl
TERRAMYCIN 343
Immersion Freshwater-reared coolwater and warmwater finfish fry and fingerlings For control of mortality in fry and fingerlings of all coolwater and warmwater species of freshwater-reared finfish due to systemic columnaris disease associated with Flavobacterium columnare 6/7/2007   Designation terminated at sponsor's request 5/5/2011
48 Zoetis Inc.
333 Portage Street
Kalamazoo, MI 49007
Oxytetracycline HCl
TERRAMYCIN 343
Immersion Freshwater-reared coolwater and warmwater finfish fry and fingerlings For control of mortality in fry and fingerlings of all coolwater and warmwater species of freshwater-reared finfish due to bacterial gill disease associated with Flavobacterium branchophilum 6/7/2007   Designation terminated at sponsor's request 5/5/2011
49 Dechra Veterinary Products
7015 College Boulevard
Suite 525
Overland Park, KS 66211
Trilostane
VETORYL
Oral Dogs For treatment of hyper- adrenocorticism due to adrenocortical tumor in dogs 8/21/2007   NADA 141-291 approved 12/05/2008
50 PetMedicus Laboratories, Inc.
101 South Main Avenue
Fourth Floor
Sioux Falls, SD 57104
Ondansetron
VML-028
Oral Dogs For prevention of cisplatin-induced emesis in dogs 8/24/2007   Designation terminated 2/17/2011
51 Western Chemical, Inc.
1269 Lattimore Road
Ferndale, WA 98248
Formalin
PARASITE-S
Immersion Freshwater-reared finfish For the control of mortality in freshwater-reared finfish due to saprolegniasis associated with fungi in the family Saprolegniaceae 12/19/2007    
52 Acrivet, Inc.
9071 South 1300 West
Suite 102
Salt Lake City, UT 84088
Deep Scleral Lamellar Cyclosporine Implant Implantation Horses For the management of severe equine recurrent uveitis (ERU) that is refractive to standard treatment and in the absence of blindness, cataract, glaucoma, or active inflammation in the affected eye or eyes 12/16/2007   Designation terminated at sponsor's request 10/28/2008
53 Western Chemical, Inc.
1269 Lattimore Road
Ferndale, WA 98248
Tricaine methanesulfonate
TRICAINE-S
Immersion Finfish For the euthanasia of finfish not intended for food 1/4/2008   Designation terminated at sponsor's request 8/25/2011
54 Intervet, Inc. (d/b/a Merck Animal Health)
556 Morris Avenue
Summit, NJ 07901
Emamectin benzoate
SLICE
Type A medicated feed Salmonids For the control of sea lice, Lepeophtheirus salmonis, Caligus elongatus, and Argulus (species to be identified) and Salmincola spp. on salmonids 2/22/2008 6/25/2010  
55 PetMedicus Laboratories, Inc.
101 South Main Avenue
Fourth Floor
Sioux Falls, SD 57104
Piroxicam
VML-030
Oral Dogs For palliation of clinical signs associated with transitional cell carcinoma (TCC) of the bladder in dogs 9/19/2008   Designation terminated 2/17/2011
56 AB Science
3, Avenue George V
75008 Paris, France
Masitinib
KINAVET CA-1
Oral Dogs For treatment of recurrent (post-surgery) or nonresectable Grade II or III cutaneous mast cell tumors in dogs that have not previously received radiotherapy and/or chemotherapy except corticosteroids 10/9/2008 12/23/2011 NADA 141-308 Conditionally approved 12/15/2010
57 AQUI-S New Zealand Ltd
Unit 5, 6 Aglionby Street
P.O. Box 44-269
Lower Hutt, New Zealand
 
Eugenol
AQUI-S 20E
Immersion Freshwater-reared coolwater finfish To sedate all freshwater-reared coolwater finfish to handleable condition 12/30/2008    
58 AQUI-S New Zealand Ltd
Unit 5, 6 Aglionby Street
P.O. Box 44-269
Lower Hutt, New Zealand
 
Eugenol
AQUI-S 20E
Immersion Freshwater-reared coolwater finfish To lightly sedate all freshwater-reared coolwater finfish for transport purposes 12/30/2008    
59 AQUI-S New Zealand Ltd
Unit 5, 6 Aglionby Street
P.O. Box 44-269
Lower Hutt, New Zealand
 
Eugenol
AQUI-S 20E
Immersion Freshwater-reared salmonid finfish To sedate all freshwater-reared salmonid finfish to handleable condition 12/30/2008    
60 AQUI-S New Zealand Ltd
Unit 5, 6 Aglionby Street
P.O. Box 44-269
Lower Hutt, New Zealand
 
Eugenol
AQUI-S 20E
Immersion Freshwater-reared salmonid finfish To lightly sedate all freshwater-reared salmonid finfish for transport purposes 12/30/2008    
61 AQUI-S New Zealand Ltd
Unit 5, 6 Aglionby Street
P.O. Box 44-269
Lower Hutt, New Zealand
 
Eugenol
AQUI-S 20E
Immersion Freshwater-reared warmwater finfish, except freshwater-reared channel catfish To sedate all freshwater-reared warmwater finfish, except freshwater-reared channel catfish, to handleable condition 12/30/2008    
62 AQUI-S New Zealand Ltd
Unit 5, 6 Aglionby Street
P.O. Box 44-269
Lower Hutt, New Zealand
 
Eugenol
AQUI-S 20E
Immersion Freshwater-reared warmwater finfish, except freshwater-reared channel catfish To lightly sedate all freshwater-reared warmwater finfish, except freshwater-reared channel catfish, for transport purposes 12/30/2008    
63 AQUI-S New Zealand Ltd
Unit 5, 6 Aglionby Street
P.O. Box 44-269
Lower Hutt, New Zealand
 
Eugenol
AQUI-S 20E
Immersion Saltwater-reared salmonid finfish To sedate all saltwater-reared salmonid finfish to handleable condition 12/30/2008    
64 AQUI-S New Zealand Ltd
Unit 5, 6 Aglionby Street
P.O. Box 44-269
Lower Hutt, New Zealand
 
Eugenol
AQUI-S 20E
Immersion Saltwater-reared salmonid finfish To lightly sedate all saltwater-reared salmonid finfish for transport purposes 12/30/2008    
65 Oasmia Pharmaceutical AB
Vallongatan 1
SE-752 28 Uppsala
Sweden
Paclitaxel
PACCAL VET
Injectable Dogs For the treatment of nonresectable Grade II and III mast cell tumors in dogs that have not received previous therapy except corticosteroids 4/6/2009    
66 Royer Biomedical Inc.
4580 Mack Ave., Suite E
Frederick, MD 21703
Cisplatin
MIII Cisplatin Beads
Implantation Horses For the local treatment of equine sarcoids up to 3 cm in diameter, excluding lesions that are flat, or those that are located within 1.5 cm of a vital anatomical structure, such as the eye, urethra, or rectum 5/1/2009    
67 Zoetis Inc.
333 Portage Street
Kalamazoo, MI 49007
Dibotermin alfa
TRUSCIENT
 
Implantation Dogs For the treatment of diaphyseal fractures as an adjunct to standard surgical care using open fracture reduction 5/15/2009  5/3/2011 Designation terminated at sponsor's request 12/18/2014
68 Frontier Scientific, Inc.
P.O. Box 31
Logan, UT 84323
Benzocaine
BENZOAK
Immersion Freshwater-reared finfish For anesthesia of freshwater-reared finfish 5/27/2009   Designation terminated at sponsor's request 12/10/2012
69 Frontier Scientific, Inc.
P.O. Box 31
Logan, UT 84323
Benzocaine
BENZOAK
Immersion Freshwater-reared finfish For sedation during transport of freshwater-reared finfish 5/27/2009   Designation terminated at sponsor's request 12/10/2012
70 Frontier Scientific, Inc.
P.O. Box 31
Logan, UT 84323
Benzocaine
BENZOAK
Immersion Freshwater-reared finfish For use as a short-term sedative for the purposes of handling freshwater-reared finfish 5/27/2009   Designation terminated at sponsor's request 12/10/2012
71 ACD Pharmaceuticals AS
Serviceboks 9-6025
Alesund, Norway
Benzocaine
BENZOAK
Immersion Saltwater-reared salmonid finfish For sedation to handleable condition for all saltwater-reared salmonids 6/22/2009   Designation terminated at sponsor's request 2/5/2015
72 ACD Pharmaceuticals AS
Serviceboks 9-6025
Alesund, Norway
Benzocaine
BENZOAK
Immersion Saltwater-reared salmonid finfish For sedation during transport of all saltwater-reared salmonids 6/22/2009   Designation terminated at sponsor's request 6/25/2013
73 AQUI-S New Zealand Ltd
Unit 5, 6 Aglionby Street
P.O. Box 44-269
Lower Hutt, New Zealand
 
Eugenol
AQUI-S 20E
Immersion Freshwater-reared channel catfish To lightly sedate all freshwater-reared channel catfish for transport purposes 7/6/2009    
74 AQUI-S New Zealand Ltd
Unit 5, 6 Aglionby Street
P.O. Box 44-269
Lower Hutt, New Zealand
 
Eugenol
AQUI-S 20E
Immersion Freshwater-reared channel catfish To sedate all freshwater-reared channel catfish to handleable condition 7/6/2009    
75 Western Chemical, Inc.
1269 Lattimore Road
Ferndale, WA 98248
Hydrogen peroxide
35% PEROX-AID
Immersion Freshwater-reared salmonids For the control of Ichthyophthirius multifiliis on freshwater-reared salmonids 9/17/2009    
76 Western Chemical, Inc.
1269 Lattimore Road
Ferndale, WA 98248
Hydrogen peroxide
35% PEROX-AID
Immersion Freshwater-reared coolwater finfish For the control of Ichthyophthirius multifiliis on freshwater-reared coolwater finfish species 9/17/2009    
77 Western Chemical, Inc.
1269 Lattimore Road
Ferndale, WA 98248
Hydrogen peroxide
35% PEROX-AID
Immersion Freshwater-reared warmwater finfish For the control of Ichthyophthirius multifiliis on freshwater-reared warmwater finfish species 9/17/2009    
78 Western Chemical, Inc.
1269 Lattimore Road
Ferndale, WA 98248
Hydrogen peroxide
35% PEROX-AID
Immersion Freshwater-reared salmonids For the control of Ichthyobodo necator on freshwater-reared salmonids 9/17/2009    
79 Western Chemical, Inc.
1269 Lattimore Road
Ferndale, WA 98248
Hydrogen peroxide
35% PEROX-AID
Immersion Freshwater-reared coolwater finfish For the control of Ichthyobodo necator on freshwater-reared coolwater finfish species 9/17/2009    
80 Western Chemical, Inc.
1269 Lattimore Road
Ferndale, WA 98248
Hydrogen peroxide
35% PEROX-AID
Immersion Freshwater-reared warmwater finfish For the control of Ichthyobodo necator on freshwater-reared warmwater finfish species 9/17/2009    
81 Western Chemical, Inc.
1269 Lattimore Road
Ferndale, WA 98248
Hydrogen peroxide
35% PEROX-AID
Immersion Freshwater-reared salmonids For the treatment and control of Gyrodactylus spp. in freshwater-reared salmonids 9/17/2009 5/22/2015  
82 Western Chemical, Inc.
1269 Lattimore Road
Ferndale, WA 98248
Hydrogen peroxide
35% PEROX-AID
Immersion Freshwater-reared coolwater finfish For the control of Gyrodactylus spp. on freshwater-reared coolwater finfish species 9/17/2009    
83 Western Chemical, Inc.
1269 Lattimore Road
Ferndale, WA 98248
Hydrogen peroxide
35% PEROX-AID
Immersion Freshwater-reared warmwater finfish For the control of Gyrodactylus spp. on freshwater-reared warmwater finfish species 9/17/2009    
84 Beeologics, Inc.
Office 1306
13th Floor, Tower II
Al Fattan Currency House
DIFC Dubai
United Arab Emirates
Israeli Acute Paralysis Virus specific dsRNA
REMEBEE
Oral Honey bees For the control of mortality associated with Israeli Acute Paralysis Virus (IAPV) in honey bees 11/2/2009   Designation terminated at sponsor's request
7/3/2014
 
85 Frontier Scientific, Inc.
P.O. Box 31
Logan, UT 84323
Lauryl methyl pyrifrin
AQUAFRIN
Immersion Freshwater-reared salmonids For control of mortality in freshwater-reared salmonids due to saprolegniasis associated with fungi in the family Saprolegniaceae 3/19/2010   Designation terminated at sponsor's request 8/9/2012
86 Intervet, Inc. (d/b/a Merck Animal Health)
556 Morris Avenue
Summit, NJ 07901
Florfenicol
AQUAFLOR
Type A medicated feed Freshwater-reared finfish, except catfish For the control of mortality due to columnaris disease associated with Flavobacterium columnare in freshwater-reared finfish, except catfish 5/28/2010 9/30/2011 NADA 141-246
approved 4/4/2012
 
87 Freeport-McMoRan Sierrita
P.O. Box 527
Green Valley, AZ 85622
 
Copper Sulfate
TRIANGLE BRAND COPPER SULFATE
Immersion Channel catfish eggs For the control of mortality in channel catfish eggs due to saprolegniasis associated with fungi of the family Saprolegniaceae 7/15/2010    
88 Zoetis Inc.
333 Portage Street
Kalamazoo, MI 49007
Tulathromycin
DRAXXIN Injectable Solution
Injectable Non-lactating goats For the treatment of respiratory disease associated with Mannheimia haemolytica in non-lactating goats 8/11/2010    
89 Zoetis Inc.
333 Portage Street
Kalamazoo, MI 49007
Tulathromycin
DRAXXIN Injectable Solution
Injectable Sheep For the treatment of respiratory disease associated with Mannheimia haemolytica in sheep 11/8/2010   Designation terminated at sponsor's request
6/12/2014
 
90 Zoetis Inc.
333 Portage Street
Kalamazoo, MI 49007
Lincomycin Hydrochloride
LINCOMIX Soluble Powder
Oral Honey Bees For the control of American Foulbrood (Paenibacillus larvae) in honey bees 11/26/2010   NADA 111-636
approved 3/27/2012
 
91 Tocagen, Inc.
3030 Bunker Hill Street #230
San Diego, CA 92109
Replication competent amphotropic murine leukemia virus with a cytosine deaminase gene (TOCA 511) and oral flucytosine (5-FC) Injectable
(intracranial) TOCA 511 followed by oral flucytosine three weeks later
Dogs For the treatment of primary malignant brain tumors in dogs 1/26/2011    
92 Intervet, Inc. (d/b/a Merck Animal Health)
556 Morris Avenue
Summit, NJ 07901
Fenbendazole
SAFE-GUARD
 
Type A medicated feed Pheasants For the removal and control of adult Syngamus trachea (gapeworm) in pheasants 2/1/2011    
93 Solvay Chemicals, Inc.
3333 Richmond Avenue
Houston, TX 77098
Hydrogen peroxide 50%
INTEROX
PARAMOVE 50
Immersion Saltwater-reared Atlantic salmon For treatment of Lepeophtheirus salmonis sea lice on saltwater-reared Atlantic salmon (Salmo salar) 4/26/2011    
94 Oasmia Pharmaceutical AB
Vallongatan 1
SE-752 28 Uppsala
Sweden
Paclitaxel
PACCAL VET
Injectable Dogs For the treatment of resectable and nonresectable squamous cell carcinoma in dogs that have not received previous chemotherapy or radiotherapy 5/19/2011  9/20/2013 NADA 141-422 Conditionally approved 2/27/2014
95 Postive Feed, Ltd.
P. O. Box 1049
Sealy, TX 77474
Ivermectin Type C medicated feed Beef cattle For the control of cattle fever ticks (Rhipicephalus microplus and R. annulatus) in beef cattle as part of the US Cattle Fever Tick Eradication Program 5/20/2011    
96 Nuovo Biologics LLC
P. O. Box 160471
Miami, FL 33116
Alpha-neurotoxoid PANAVIRA Injectable Dogs For the treatment of local disease in stage II and III oral malignant melanoma in dogs 7/27/2011    
97 Intervet, Inc. (d/b/a Merck Animal Health)
556 Morris Avenue
Summit, NJ 07901
Florfenicol
AQUAFLOR
Type A medicated feed Freshwater-reared salmonids For the control of mortality in freshwater-reared salmonids due to bacterial kidney disease (BKD) associated with Renibacterium salmoninarum 8/3/2011    
98 ECO Animal Health
344 Nassau Street
Princeton, NJ 08540
 
Tylvalosin
AIVLOSIN
 
Oral Pheasants For the control of respiratory infections associated with Mycoplasma gallisepticum in pheasants 9/28/2011    
99 Fish Vet Group LTD.
22 Carsegate Road
Inverness, Scotland IV3 8EX
Azamethiphos
SALMOSAN
Immersion Saltwater-reared Atlantic salmon For the treatment and control of adult and pre-adult Lepeophtheirus salmonis sea lice on saltwater-reared Atlantic salmon (Salmo salar) 9/30/2011    
100 Eagle Aquaculture, Inc.
300 North Dean Road
Suite 5
Auburn, AL 36830
Luteinizing Hormone-Releasing Hormone analog (LHRHa) Injectable Channel catfish For use as a spawning aid for female channel catfish (Ictalurus punctatus) 10/6/2011    
101 Eagle Aquaculture, Inc.
300 North Dean Road
Suite 5
Auburn, AL 36830
Luteinizing Hormone-Releasing Hormone analog (LHRHa) Implantation Channel catfish For use as a spawning aid for female channel catfish (Ictalurus punctatus) 10/6/2011    
102 Oasmia Pharmaceutical AB
Vallongatan 1
SE-752 28 Uppsala
Sweden
Paclitaxel
PACCAL VET
 
Injectable Dogs For the treatment of nonresectable stage III, IV or V mammary carcinoma in dogs that have not received previous chemotherapy or radiotherapy 12/22/2011  9/10/2013 NADA 141-422 Conditionally approved 2/27/2014
103 Pathogenes, Inc.
P.O. Box 970
Fairfield, FL 32634
 
Decoquinate/Levamisole
OROGIN
 
Oral Horses For the treatment of equine protozoal myeloencephalitis caused by Sarcocystis neurona in horses 5/7/2012    
104 Oasmia Pharmaceutical AB
Vallongatan 1
SE-752 28 Uppsala
Sweden
Doxorubicin
DOXOPHOS VET
Injectable Dogs For the treatment of lymphoma in dogs 6/27/2012    
105 Novartis Animal Health US, Inc.
3200 Northline Avenue
Suite 300
Greensboro, NC 27408
Monepantel
ZOLVIX
Oral Sheep For the treatment and control of gastrointestinal nematodes in sheep at the adult stage, including Haemonchus contortus, Teladorsagia circumcincta, Trichostrongylus colubriformis, Trichostrongylus axei, and Cooperia curticei 7/3/2012    
106 Novartis Animal Health US, Inc.
3200 Northline Avenue
Suite 300
Greensboro, NC 27408
Monepantel
ZOLVIX
Oral Goats For the treatment and control of gastrointestinal nematodes in goats at the adult stage, including Haemonchus contortus, Teladorsagia circumcincta, Trichostrongylus colubriformis, Trichostrongylus axei, and Cooperia curticei 7/3/2012   Designation terminated at sponsor's request 4/23/2014
107 Zoetis Inc.
333 Portage Street
Kalamazoo, MI 49007 
Gonadotropin Releasing Factor Analog-Diphtheria Toxoid conjugate
IMPROVEST
 
Injectable Swine For the immunological castration and reduction of male aggressive and sexual behavior in cull adult breeding boars intended for slaughter 8/14/2012    
108 Bayer HealthCare LLC
P.O. Box 390
Shawnee Mission, KS 66201
 
Imidacloprid/Moxidectin
ADVANTAGE MULTI for Cats
 
Topical Ferrets For the prevention of heartworm disease in ferrets caused by Dirofilaria immitis; ADVANTAGE MULTI for Cats kills adult fleas (Ctenocephalides felis) and is indicated for the treatment of flea infestations on ferrets 8/29/2012   NADA 141-254 approved 10/31/2013
109 Therapeutic Vision, Inc.
11778 Whitmore Street
Omaha, NE 68142
 
2-methyl sorbinil
KINOSTAT
 
Ophthalmic Dogs For the prevention of diabetic cataracts in dogs with diabetes mellitus 9/10/2012    
110 Zoetis Inc.
333 Portage Street
Kalamazoo, MI 49007
Lasalocid sodium
AVATEC
 
Type A medicated feed Pheasants For the control of coccidiosis associated with Eimeria spp. in pheasants 10/25/2012    
111 Hybrid Catfish Company
1233 Montgomery Drive
Inverness, MS 38753
 
Catfish pituitary Injectable Channel catfish For use as a spawning aid for female channel catfish 11/8/2012    
112 VetDC, Inc.
150 N. County Rd. 3
Fort Collins, CO 80524
 
Rabacfosadine
succinate
TANOVEA
 
Injectable Dogs For the treatment of lymphoma in dogs 11/20/2012 6/18/2013  
113 Pathogenes, Inc.
P.O. Box 970
Fairfield, FL 32634
 
Levamisole HCl
NEUROQUEL
 
Oral Horses For the control of residual or recurrent clinical signs due to inflammation associated with Equine Protozoal Myeloencephalitis (EPM) following anti-protozoal therapy 3/5/2013    
114 Karyopharm Therapeutics, Inc.
2 Mercer Road
Natick, MA 01760
 
KPT-335
[a Selective Inhibitor of Nuclear Export (SINE)]
 
Oral Dogs For the treatment of lymphoma in dogs 4/3/2013    
115 Pharmgate LLC
161 North Franklin Turnpike
Suite 2C
Ramsey, NJ 07446
Oxytetracycline HCl
PENNOX 343
Immersion Ornamental finfish For the control of mortality due to external columnaris disease associated with Flavobacterium columnare in freshwater-reared ornamental finfish 7/3/2013    
116 Pharmgate LLC
161 North Franklin Turnpike
Suite 2C
Ramsey, NJ 07446
Oxytetracycline HCl
PENNOX 343
Immersion Freshwater-reared salmonid fry and fingerlings For the control of mortality due to coldwater disease associated with Flavobacterium psychrophilum in freshwater-reared salmonid fry and fingerlings 7/3/2013    
117 Pharmgate LLC
161 North Franklin Turnpike
Suite 2C
Ramsey, NJ 07446
Oxytetracycline HCl
PENNOX 343
Immersion Fry and fingerling freshwater-reared nonsalmonid finfish, excluding ornamental finfish For the control of mortality due to bacterial gill disease associated with Flavobacterium spp. in fry and fingerling freshwater-reared nonsalmonid finfish, excluding ornamental finfish 7/8/2013    
118 Pharmgate LLC
161 North Franklin Turnpike
Suite 2C
Ramsey, NJ 07446
Oxytetracycline HCl
PENNOX 343
Immersion Fry and fingerling freshwater-reared nonsalmonid finfish, excluding ornamental finfish For the control of mortality due to external columnaris disease associated with Flavobacterium columnare in fry and fingerling freshwater-reared nonsalmonid finfish, excluding ornamental finfish 7/8/2013    
119 Ogenx Therapeutics Corporation
1290 Gulf Blvd., Suite 1201
Clearwater, FL 33767
RC-2B
(geroxane)
Injectable Dogs For the treatment of lymphoma in dogs 8/5/2013    
120 Ogenx Therapeutics Corporation
1290 Gulf Blvd., Suite 1201
Clearwater, FL 33767
RC-2B
(geroxane)
Injectable Dogs For the treatment of nonresectable Grade II and III mast cell tumors in dogs that have not received previous therapy except corticosteroids 8/5/2013    
121 Compan Pharmaceuticals, LLC
15434 Bridgewater Club Blvd.
Carmel, IN 46033
Piroxicam Oral Dogs For the treatment of transitional cell carcinoma (TCC) of the bladder in dogs 10/22/2013    
122 Western Chemical, Inc.
1269 Lattimore Road
Ferndale, WA 98248
Strontium chloride hexahydrate Immersion Pacific salmon fry For the skeletal marking of Pacific salmon fry in freshwater 11/7/2013    
123 AQUI-S New Zealand Ltd
Unit 5, 6 Aglionby Street
P.O. Box 44-269
Lower Hutt, New Zealand
 
Eugenol
AQUI-S 20E
 
Immersion Saltwater finfish To sedate saltwater finfish, except for saltwater salmonids, to handleable condition 3/3/2014    
124 Axcentive SARL
Akzo-Nobel Services, Inc.
525 West Van Buren Street
Chicago, IL 60607
 
Chloramine-T
HALAMID AQUA
 
Immersion Freshwater-reared finfish (except walleye) For the control of mortality in all freshwater-reared coolwater finfish (except walleye) due to external columnaris disease associated with Flavobacterium columnare 3/17/2014    
125 Solvay Chemicals, Inc.
3333 Richmond Avenue
Houston, TX 77098
 
Hydrogen peroxide
50%
INTEROX
PARAMOVE 50
 
Immersion Saltwater-reared Atlantic salmon For treatment of amoebic gill disease (Neoparamoeba spp.) on saltwater-reared Atlantic salmon (Salmo salar) 6/25/2014    
126 Assisi Research Laboratories, LLC
7115 West North Avenue, #505
Oak Park, IL 60302
 
Asparaginase Injectable Dogs For the induction of remission of multicentric lymphoma in dogs 2/6/2015    
127 Nexcyon Pharmaceuticals, Inc.
644 West Washington Avenue
Madison, WI 53703
ACTH 1-24 Adrenocorticotropic hormone Injectable Dogs For use as a diagnostic aid in testing for adrenal insufficiency in dogs 5/15/2015    
128 Western Chemical, Inc.
1269 Lattimore Road
Ferndale, WA 98248
Hydrogen peroxide
35% PEROX-AID
Immersion Freshwater-reared warmwater finfish (except channel catfish) For the control of mortality in freshwater-reared warmwater finfish (except channel catfish) due to external columnaris disease associated with Flavobacterium columnare 5/22/2015    

 

Page Last Updated: 05/28/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.