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Table of Contents

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New Animal Drug Applications

Environmental Assessments & Finding of No Significant Impact
Sorted By NADA Number

NADA Nos. link to the FOI Summary Abstract
EA = Environmental Assessment
FONSI = Finding of No Significant Impact

NADA No.

Trade Name

Generic Name

007-891

EA
FONSI

3-Nitro® 10; 20; 50; 80 Type A Medicated Article for Growing Chicken, Turkey & Swine 

Roxarsone

011-315

EA
FONSI

Neomix® 325 and Neomix® 325 Soluble Powder for Cattle, Swine, Sheep and Goats 

Neomycin Sulfate

011-315

EA
FONSI

Neomix® 325 and Neomix® AG 325 Soluble Powder for Growing Turkey 

Neomycin Sulfate

012-123

EA
FONSI

Gallimycin® Injectable for Cattle 

Erythromycin

012-375

EA
FONSI

Albamix® Feed Medication for Ducks 

Novobiocin

034-254

EA
FONSI

MGA® 100/200 Premix for Heifers 

Melengestrol Acetate

038-233

EA
FONSI

Ralgro® Implants for Feedlot Steers 

Zeranol

038-439

EA
FONSI

Terramycin® Premix for use in Lobster 

Oxytetracycline

039-402

EA
FONSI

MGA® 500 Liquid Premix for Heifers 

Melengestrol Acetate

039-417

EA
FONSI

Deccox® Type A Medicated Article for Sheep 

Decoquinate

040-209

EA
FONSI

Rofenaid® 40 Type A Medicated Article for Duck 

Sulfadimethoxine and Ormetoprim

044-759

EA
FONSI

Flavomycin® Type A Medicated Article for Turkey 

Bambermycins

044-759

EA
FONSI

Flavomycin® Type A Medicated Article for Cattle 

Bambermycins

046-592

EA
FONSI

BMD® Type A Medicated Article for Chickens, Turkey, Swine, Cattle, Pheasant and Quail 

Bacitracin Methylene Disalicylate

046-592

EA
FONSI

BMD ® Type A Medicated Article 

Bacitracin Methylene Disalicylate

065-280

EA
FONSI

Soluble Fortracin Concentrate for Chicken and Turkey 

Bacitracin Methylene Disalicylate

091-467

EA
FONSI

Stafac® 500 Type A Medicated Feed for Turkey 

Virginiamycin

091-467

EA
FONSI

Stafac® 500 Type A Medicated Article for Swine 

Virginiamycin

091-513

EA
FONSI

Stafac® Type A Medicated Article for Swine 

Virginiamycin

092-444

EA
FONSI

Rumatel ® 88 Type A Medicated Article for Goat 

Morantel Tartrate

093-025

EA
FONSI

3-Nitro® Soluble; 3-Nitro® W for Growing Chicken, Turkey and Swine 

Roxarsone

093-903

EA
FONSI

Rumatel® Cattle Wormer Bolus 

Morantel tartrate

095-735

EA
FONSI

Rumensin Type A Medicated Article for Cattle 

Monensin Sodium

095-735

EA
FONSI

Rumensin® Type C Medicated Feed for Goat 

Monensin

096-298

EA
FONSI

Avatec® Type A Medicated Article for Turkey 

Lasalocid

097-505

EA
FONSI

Lincomix® 20 Feed Medications for Swine 

Lincomycin Hydrochloride Monohydrate

098-452

EA
FONSI

Albac® 50 Type A Medicated Article for Laying Hens 

Bacitracin Zinc

101-479

EA
FONSI

Banamine® Injectable Solution for Cattle 

Flunixin Meglumine

101-862

EA
FONSI

Garasol® Injection for Chicken 

Gentamicin Sulfate

106-964

EA
FONSI

Apralan® Soluble Powder for Swine 

Apramycin Sulfate

110-048

EA
FONSI

Valbazen® Oral Suspension for Goat, Sheep and Cattle 

Albendazole

110-315

EA
FONSI

IMPLUS-C® Implants for Calves 

Progesterone and Estradiol Benzoate

113-232

EA
FONSI

Liquamycin® LA-200® Injectable solution for Lactating Dairy Cattle 

Oxytetracycline amphoteric

115-732

EA
FONSI

Stresnil Injection for Swine 

Azaperone

118-980

EA
FONSI

Monteban® Premix for Broiler Chickens 

Narasin

125-933

EA
FONSI

Romet®-30 Type A Medicated Article for Salmonid Fish 

Sulfadimethoxine and Ormetoprim

126-050

EA
FONSI

Apralan® 75 Soluble Powder for Swine 

Apramycin Sulfate

128-409

EA
FONSI

Ivomec® 1% Injection for Swine 

Ivermectin

128-620

EA
FONSI

Safe-Guard® 10% Suspension, Panacur® 10% Suspension for Beef and Dairy Cattle 

Fenbendazole

128-686

EA
FONSI

Bio-Cox® Type A Medicated Article for Chicken 

Salinomycin

130-435

EA
FONSI

Oxy-Tet ™ Soluble Powder for Swine 

Oxytetracycline Hydrochloride

130-736

EA
FONSI

Coban® Type A Medicated Article for Turkey 

Monensin

130-736

EA
FONSI

Coban® 45 in the Feed of Turkey 

Monensin Sodium

130-951

EA
FONSI

Stenorol® Premix for Chicken 

Halofuginone hydrobromide

131-392

EA
FONSI

Ivomec® 0.08% Oral Solution for Sheep 

Ivermectin

131-675

EA
FONSI

Safe-Guard® OTC Premix for Swine 

Fenbendazole

131-675

EA
FONSI

Safe-Guard® Type A Medicated Article for Wildlife Animals 

Fenbendazole

132-872

EA
FONSI

Safe-Guard® 10% Paste, Panacur® 10% Paste for Beef and Dairy Cattle 

Fenbendazole

134-779

EA
FONSI

Paratect Flex ™ Sustained release cylinder for Cattle 

Morantel Tartrate

135-906

EA
FONSI

Component® E-H with Tylan® Implants for Cattle 

Testosterone Propionate, Estradiol Benzoate, and Tylosin Tartrate

136-742

EA
FONSI

Curatrem® Drench 8.5% Oral Suspension for Cattle 

Clorsulon

137-600

EA
FONSI

Safe-Guard® Type A Medicated Article for Cattle 

Fenbendazole

138-612

EA
FONSI

Finaplix®-H; Finaplix®-S Ear Implant for Feedlot Heifers and Steers 

Trenbolone acetate

138-903

EA
FONSI

Porcilene® Sterile Solution for Swine, Gilts; Swine, Sows 

Fenprostalene

139-075

EA
FONSI

Cygro® Type A Medicated Article for Broiler Chickens 

Maduramicin ammonium

139-472

EA
FONSI

Denagard® 5 \ Denagard® 10 Medicated Premix; Denagard® Antibiotic Premix for Swine 

Tiamulin

139-472

EA
FONSI

Denagard® 5 \ Denagard® 10 Medicated Premix; Denagard® Antibiotic Premix for Swine - Supplement 

Tiamulin

140-338

EA
FONSI

Naxcel® Sterile Powder for Beef and Lactating Dairy Cattle 

Ceftiofur Sodium

140-338

EA
FONSI

Naxcel® Sterile Powder for Turkey 

Ceftiofur Sodium

140-818

EA
FONSI

Producil® Medicated Feed Premix for Swine 

Efrotomycin

140-824

EA
FONSI

Stenorol® Type C Medicated Feed for Turkey 

Halofuginone Hydrobromide

140-828

EA
FONSI

Baytril® 3.23% Concentrate Antimicrobial Solution for Chicken and Turkey 

Enrofloxacin

140-841

EA
FONSI

Ivomec® Pour-On for Cattle 

Ivermectin

140-854

EA
FONSI

Synanthic® 9.06% & 22.5% Suspension for Beef & Dairy Cattle 

Oxfendazole

140-863

EA
FONSI

Paylean® Type A Medicated Article for Swine 

Ractopamine HCl

140-872

EA
FONSI

Posilac® Sterile Injectable for Cattle 

BST; Bovine Somatotropin, Bovine Growth Hormone, Sometribove

140-890

EA
FONSI

Excenel ® 1.0 mg Sterile Suspension for Cattle 

Ceftiofur HCl

140-890

EA
FONSI

Excenel ® 0.5 mg Sterile Suspension for Cattle 

Ceftiofur HCl

140-897

EA
FONSI

Revalor®-S Implants for Feeder Steers 

Trenbolone Acetate and Estradiol

140-897

EA
FONSI

Revalor®-G Implants for Heifers 

Trenbolone Acetate and Estradiol

140-929

EA
FONSI

Micotil® 300 Injectable Solution for Cattle 

Tilmicosin Phosphate

140-940

EA
FONSI

Aviax ™ Premix for Broiler Chickens 

Semduramicin

140-951

EA
FONSI

Clinacox ™ Type A Medicated Article for Chicken and Turkey 

Diclazuril

140-974

EA
FONSI

Ivomec® Premix Type A Medicated Article for Swine 

Ivermectin

140-988

EA
FONSI

Ivomec® Sustained-Release Bolus for Cattle 

Ivermectin

140-989

EA
FONSI

Parasite-S® in the environmental water for Fish 

Formalin

140-992

EA
FONSI

Revalor®-H Implant tablets for Heifers 

Trenbolone Acetate and Estradiol

140-998

EA
FONSI

V-Max ™ Type A Medicated Article for Cattle 

Virginiamycin

141-025

EA
FONSI

Cattlyst® Type A Medicated Article for Feedlot Cattle 

Laidlomycin Propionate Potassium

141-036

EA
FONSI

Pirsue® Aqueous Gel for use in Lactating Dairy Cattle 

Pirlimycin Hydrochloride

141-043

EA
FONSI

Synovex® Plus Implants for Steers 

Trenbolone Acetate and Estradiol

141-061

EA
FONSI

Dectomax® Injectable Solution for Cattle and Swine 

Doramectin

141-061

EA
FONSI

Dectomax® Injectable Solution for Cattle 

Doramectin

141-063

EA
FONSI

Nuflor® Injectable Solution for Cattle 

Florfenicol

141-064

EA
FONSI

Pulmotil® 90 Type A Medicated Article for Swine 

Tilmicosin

141-069

EA
FONSI

First Guard™ Sterile Powder for Chicken 

Colistimethate Sodium

141-074

EA
FONSI

Trexonil® Sterile Injectable for Elk, Moose and Wildlife Animals 

Naltrexone HCl

141-077

EA
FONSI

Adspec® Sterile Solution for Cattle 

Spectinomycin Sulfate

141-079

EA
FONSI

Ivomec® Eprinex ™ Pour-On for Beef and Dairy Cattle 

Eprinomectin

141-095

EA
FONSI

Dectomax® Pour-on Solution for Cattle 

Doramectin

141-099

EA
FONSI

CYDECTIN® 0.5% Pour-On for Cattle 

Moxidectin

141-200

EA
FONSI

EAZI-Breed™ CIDR® Cattle Insert 

Progesterone Insert (Intravaginal)

141-207

EA
FONSI

Advocin® 180 Sterile Antimicrobial Injectable Solution for Cattle 

Danofloxacin Mesylate

141-246

EA
FONSI

Aquaflor® Type A Medicated Article (florfenicol) 

Florfenicol

141-255

EA
FONSI

35% PEROX-AID for Freshwater-reared Finfish 

Hydrogen peroxide Liquid solution

Web Page Updated by mdt - February 16, 2007, 12:35 PM ET




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