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U.S. Department of Health and Human Services

Animal & Veterinary

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140-531 to 140-920

NADA 140-531 original approval
Sponsor: Agri-Basics
Generic Name: tylosin (as tylosin phosphate)
Trade Name: Tylan 5, 10, 20 & 40 Premix
Indications for Use: SWINE: For increased rate of weight gain and improved feed efficiency. BEEF CATTLE: For reduction of incidence of liver abscesses caused by Sphaerophorus necrophorus and Corynebacterium pyogenes . CHICKENS: For increased rate of weight gain and improved feed efficiency. LAYING CHICKENS: Improving feed efficiency. BROILER AND REPLACEMENT CHICKENS: To aid in the control of chronic respiratory disease caused by Mycoplasma gallisepticum .
Date of Approval: July 26, 1986

NADA 140-533 original approval
Sponsor: Roussel-Uclaf
Generic Name: bacitracin methylene disalicylate, roxarsone, halofuginone hydrobromide
Trade Name: Bacitracin MD, 3-Nitro, Stenorol
Indications for Use: For the prevention of coccidiosis caused by E. tenella, E. acervulina, E. maxima, E. brunetti, E. necatrix and E. mivati ; For increased rate of weight gain and for improved feed efficiency in broiler chickens.
Date of Approval: January 11, 1988

NADA 140-578 original approval
Sponsor: Vetri-Tech, Inc.
Generic Name: tetracycline hydrochloride
Trade Name: Solu-Tet 324
Indications for Use: Chickens: Control of chronic respiratory disease (CRD) and air sac infection caused by Mycolplasma gallisepticum and Esherichia coli; infectious synovitis caused by Mycoplasma synoviae susceptible to otetracycline.
Date of Approval: February 26, 1991

NADA 140-579 original approval
Sponsor: Hoffmann-LaRoche, Inc.
Generic Name: lasalocid sodium, oxytetracycline (monoalkyl trimethyl ammonium salt)
Trade Name: Bovatec®, Terramycin
Indications for Use: For improved feed efficiency, increased rate of weight gain and reduction of the incidence and severity of liver abscesses in beef cattle fed in confinement for slaughter.
Date of Approval: December 18, 1987

NADA 140-581 original approval
Sponsor: A. H. Robbins Company, Inc.
Generic Name: salinomycin, roxarsone, and lincomycin
Trade Name: Bio-Cox®, 3-Nitro®, and Lincomix® (combined use)
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati including some field strains of E. tenella that are more susceptible to roxarsone combined with salinomycin than to salincomycin alone; and for improved feed efficiency.
Date of Approval: May 31, 1989

NADA 140-582 original approval
Sponsor: Anthony Products Co.
Generic Name: oxytetracycline HCl
Trade Name: Oxytetracycline Hydrochloride Injection, 50 mg and 100 mg
Indications for Use: Oxytetracycline HCl (50 mg and 100 mg) is intended for use in the treatment of the following diseases in beef cattle and non-lactating dairy cattle when due to oxytetracycline-susceptible organisms: pneumonia and shipping fever complex associated with Pasteurella spp. and Hemophilus spp.; foot-rot and diphtheria caused by Fusobacterium necrophorum;bacterial enteritis (scours) caused by Escherichia coli; wooden tongue caused by Actinobacillus lignieresii; leptospirosis caused by Leptospira pomona; and wound infections and acute metritis caused by strains of staphylococci and streptococci organisms sensitive to oxytetracycline. If the product contains the statement "Federal law restricts this drug to use by or on the order of a licensed veterinarian," it may contain additional directions for use in beef cattle and non-lactating dairy cattle for the treatment of anaplasmosis caused by Anaplasma marginale and anthrax caused by Bacillus anthracis.
Date of Approval: March 15, 1988

NADA 140-583 original approval
Sponsor: Anthony Products Company
Generic Name: repository corticotropin injection
Trade Name: ACTH Gel
Indications for Use: ACTH (adrenocorticotropic hormone) stimulates the production of cortical hormones by the adrenal cortex. Corticotropin Injection is indicated primarily for use as a diagnostic aid to test for adrenal dysfunction in dogs. The product is also indicated for stimulation of the adrenal cortex, where there is a general deficiency of ACTH in dogs and cats.
Date of Approval: November 14, 1988

NADA 140-584 original approval
Sponsor: Roussel-Uclaf; Hoechst-Roussel Agri-Vet Company
Generic Name: bacitracin methylene disalicylate; halofuginone hydrobromide
Trade Name: Bacitracin MD; Stenorol
Indications for Use: For the prevention of coccidiosis by Eimeria acervulina, E. brunetti, E. maxima, E. mivati, E. necatrix, and E. tenella and improved feed efficiency in broiler chickens.
Date of Approval: March 16, 1988

NADA 140-680 original approval
Sponsor: Penfield Chemical Corporation
Generic Name: tylosin (as tylosin phosphate)
Trade Name: Tylan 5, 10, 20 & 40 Premix
Indications for Use: SWINE: For increased rate of weight gain and improved feed efficiency. For prevention of swine dysentery (vibrionic). For maintaining weight gains and feed efficiency in the presence of atrophic rhinitis. For the treatment and control of swine dysentery (vibrionic) following initial medication of Tylan Plus Vitamins in drinking water. BEEF CATTLE: For reduction in the incidence of liver abscesses caused by Sphaerophorus necrophorus and Corynebacterium pyogenes . CHICKENS: For increased rate of weight gain and improved feed efficiency. LAYING CHICKENS: Improving feed efficiency. BROILER AND REPLACEMENT CHICKENS: To aid in the control of chronic respiratory disease caused by Mycoplasma gallisepticum .
Date of Approval: July 24, 1987

NADA 140-681 original approval
Sponsor: Pennfield Chemical Corporation
Generic Name: tylosin (as tylosin phosphate) combined with sulfamethazine
Trade Name: Tylan 5, 10, 20, & 40 Sulfa-G Premixes
Indications for Use: For maintaining weight gains and feed efficiency in the presence of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery (vibrionic); control of swine pneumonia caused by bacterial pathogens (Pasteurella multocida and/or Corynebacterium pyogenes). Feeds containing Tylosin and Sulfamethazine must be withdrawn 15 days before swine are slaughtered.
Date of Approval: July 30, 1987

NADA 140-684 original approval
Sponsor: Fort Dodge Laboratories, Inc.
Generic Name: cefadroxil
Trade Name: CEFA-DROPS (cefadroxil) Veterinary Powder for Oral Suspension
Indications for Use: CEFA-DROPS (cefadroxil) is indicated for the treatment of the following conditions: DOGS: Genitourinary tract infections (cystitis) caused by susceptible strains of Escherichia coli, Proteus mirabilis, and Staphylococcus aureus . Skin and soft tissue infections including cellulitis, pyoderma, dermatitis, wound infections and abscesses caused by susceptible strains of Staphylococcus aureus . CATS: Skin and soft tissue infections including abscesses, wound infections, cellulitis and dermatitis caused by susceptible strains of Pasteurella multocida, Staphylococcus aureus, Staphylococcus epidermidis, and Streptococcus spp.
Date of Approval: July 20, 1988

NADA 140-806 original approval
Sponsor: Fort Dodge Laboratories
Generic Name: hyaluronate sodium
Trade Name: Hyalovet®
Indications for Use: For the intra-articular treatment of carpal or fetlock joint dysfunction in horses due to acute or chronic, non-infectious synovitis associated with equine osteoarthritis.
Date of Approval: May 31, 1988

NADA 140-810 original approval
Sponsor: Biomed Laboratories
Generic Name: nystatin, neomycin sulfate, thiostrepton, triamcinolone acetonide ointment
Trade Name: Panavet Ointment
Indications for Use: Panavet Ointment (nystatin, neomycin sulfate, thiostrepton, triamcinolone acetonide ointment) is particularly useful in the treatment of acute and chronic otitis of varied etiologies, in interdigital cysts in cats and dogs, and in anal gland infections in dogs. The preparation is also indicated in the management of dermatologic disorders characterized by inflammation and dry or exudative dermatitis, particularly those cause, complicated, or threatened by bacterial or candidal (Candida albicans) infections. It is also of value in eczematous dermatitis, contact dermatitis, and seborrheic dermatitis, and as an adjunct in the treatment of dermatitis due to parasitic infestation.
Date of Approval: February 3, 1989

NADA 140-818 original approval
Sponsor: Merck Research Laboratories
Generic Name: efrotomycin
Trade Name: Producil
Indications for Use: For increased rate of weight gain when incorporated into complete swine feeds at 3.6 to 14.5 g/tons; for improved feed efficiency when incorporated into complete swine feeds at 3.6 g/ton.
Date of Approval: July 24, 1992

NADA 140-819 original approval
Sponsor: Pfizer Inc.
Generic Name: pyrantel tartrate
Trade Name: Strongid 48
Indications for Use: For the prevention of Strongylus vulgaris larval infections in horses. For control of the following parasites in horses: LARGE STRONGYLES (adults) S. vulgaris, S. edentatus, Triodontophorus spp. SMALL STRONGYLES (adult and fourth-stage larvae) Cyathostomum spp. Cylicocyclus spp., Cylicostephanus spp., Cylicodontophorus spp., Poteriostomum spp., PINWORMS (adult and fourth-stage larvae) Oxyuris equi ASCARIDS (adult and fourth-stage larvae) Parascaris equorum.
Date of Approval: April 18, 1990

NADA 140-819 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: pyrantel tartrate
Trade Name: Strongid® 48
Effect of Supplement: This supplement provides for revised feeding instructions. It also provides for movement of the parasite Triodontophorus spp. from the Large Strongyles to the Small Strongyles in the indications section.
Date of Approval: August 24, 1999

NADA 140-820 original approval
Sponsor: Furst-McNess Company
Generic Name: tylosin (as tylosin phosphate) combined with sulfamethazine
Trade Name: Tylan 5, 10, 20 & 40 Sulfa-G Premixes
Indications for Use: For maintaining weight gains and feed efficiency in the presence of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery (vibrionic); control of swine pneumonias caused by bacterial pathogens (Pasteurella multocida and/or Corynebecterium pyogenes ). Feeds containing Tylosin and Sulfamethazine must be withdrawn 15 days before swine are slaughtered.
Date of Approval: January 9, 1987

NADA 140-824 supplemental approval
Sponsor: Roussel Uclaf
Generic Name: halofuginone hydrobromide
Trade Name: Stenorol®
Effect of Supplement: Change of tolerance.
Date of Approval: April 14, 1992

NADA 140-825 original approval
Sponsor: Furst-McNess Company
Generic Name: pyrantel tartrate
Trade Name: Swine Wormer-B
Indications for Use: CONTINUOUS FEEDING PROGRAM: For aid in the prevention of migration and establishment of large round worm (Ascaris suum )infections; for aid in the prevention of establishment of nodular worm (Oesophagostomum ) infections of swine. Feed continuously as the sole ration. THREE DAY THERAPEUTIC PROGRAM: For the removal and control of large roundworm (Ascaris suum ) infections of swine. Feed for three days as the sole ration. SINGLE THERAPEUTIC PROGRAM: For the removal and control of large roundworm (Ascaris suum ) and nodular worm (Oesphagostomum ) infections of swine. Withdraw this feed 24 hours prior to slaughter.
Date of Approval: September 24, 1986

NADA 140-828 original approval
Sponsor: BAYER Corporation
Generic Name: enrofloxacin
Trade Name: Baytril® (enrofloxacin) 3.23% Concentrate Antimicrobial Solution
Indications for Use: Chickens - Baytril® (enrofloxacin) 3.23% Concentrate Antimicrobial Solution is indicated for the control of mortality associated with E. coli susceptible to enrofloxacin.
Turkeys - Baytril® (enrofloxacin) 3.23% Concentrate Antimicrobial Solution is indicated for the control of mortality associated with E. coli and P. multocida (fowl cholera) susceptible to enrofloxacin.
Date of Approval: October 4, 1996

NADA 140-831 original approval
Sponsor: Argent Chemical Laboratories, Inc.
Generic Name: formalin
Trade Name: Paracide-F
Indications for Use: a. Formalin is indicated for the control of external parasites on cultured sport and food fishes: salmon, trout, catfish, largemouth bass, and bluegill. b. For control of fungi of the family Saprolegniaceae on salmon, trout, and esocid eggs.
Date of Approval: February 3, 1989

NADA 140-833 original approval
Sponsor: Merck Sharp & Dohme Research Laboratories
Generic Name: ivermectin and clorsulon
Trade Name: Ivomec-F® Injection For Cattle
Indications for Use: Ivomec-F Injection For Cattle is indicated for the treatment and control of the following species of gastrointestinal nematodes, lungworms, liver flukes, grubs, sucking lice, and mange mites of cattle.
Date of Approval: November 15, 1989

NADA 140-833 supplemental approval
Sponsor: Merck & Co., Inc.
Generic Name: ivermectin and clorsulon
Trade Name: Ivomec® Plus Injection for Cattle.
Effect of Supplement: New claims for persistent control of gastrointestinal roundworms and lungworms.
Date of Approval: February 24, 1997

NADA 140-833 supplemental approval
Sponsor: Merial Limited
Generic Name: ivermectin and clorsulon
Trade Name: Ivomec® Plus Injection for Cattle
Indications for Use: This supplemental application extends the period of persistent effect against infections of Dictyocaulus viviparus from 21 days to 28 days.
Date of Approval: March 21,1989

NADA 140-833 supplemental approval
Sponsor: Merial Limited
Generic Name: ivermectin and clorsulon
Trade Name: Ivomec® Plus Injection for Cattle
Effect of Supplement: "...has been proved to effectively control infections and to protect from re-infection with Dictyocaulus viviparus for 28 days after treatment."
Date of Approval: April 1,1999

NADA 140-833 supplemental approval
Sponsor: Merial Limited
Generic Name: Ivermectin, clorsulon
Trade Name: Ivomec® Plus Injection for Cattle
Effect of Supplement: To extend the persistent effect periods for Oesophagostomum radiatum from 14 to 28 days after treatment and Cooperia punctata and Trichostrongylus axei from 14 to 21 days after treatment. At this time, the labeling is being revised to reflect updated environmental information and to add the veal calf warning statement to the residue information section.
Date of Approval: April 21, 2004

NADA 140-839 original approval
Sponsor: Beecham Laboratories
Generic Name: mupirocin
Trade Name: BACTODERM®
Indications for Use: BACTODERM® Ointment is indicated for the topical treatment of canine bacterial infections of the skin, including superficial pyoderma, caused by susceptible strains of the following organisms: Staphylococcus aureus and Staphylococcus intermedius.
Date of Approval: September 28, 1988

NADA 140-841 original approval
Sponsor: Merck Sharp and Dohme Research Laboratories
Generic Name: Ivermectin
Trade Name: IVOMEC Pour-On for Cattle
Indications for Use: For the treatment and control of gastrointestinal nematodes, lungworms, cattle grubs, sucking and biting lice, and sarcoptic mange mites.
Date of Approval: August 30, 1990

NADA 140-841 supplemental approval
Sponsor: Merck & Co.
Generic Name: ivermectin
Trade Name: Ivomec Pour-On® for Cattle
Effect of Supplement: New claims for persistent control of gastrointestinal roundworms
Date of Approval: June 5, 1997

NADA 140-841 supplemental approval
Sponsor: Merial Ltd.
Generic Name: Ivermectin
Trade Name: Ivomec (ivermectin) Pour-On for Cattle
Effect of Supplement: To add the new persistent activity indications for Dictyocaulus viviparus for 28 days after treatment, Cooperia surnabada for 14 days after treatment, and Damalinia bovis for 56 days after treatment. To extend the persistent activity periods for Oesophagostomum radiatum from 14 to 28 days after treatment and Cooperia punctata and Trichostrongylus axei from 14 days to 21 days after treatment. At this time, the labeling is being revised to reflect updated environmental information, to speciate Cooperia spp in the treatment and control section of the indications, and to add the veal calf warning statement to the residue information section.
Date of Approval: November 24, 2003

NADA 140-842 original approval
Sponsor: MacPage, Inc.
Generic Name: hygromycin B
Trade Name: Hygromix 2.4 Premix
Indications for Use: SWINE: Control of infestations of large roundworms, nodular worms and whipworms . CHICKENS: Control of infestations of large roundworms, cecal worms, and capillary worms.
Date of Approval: August 5, 1987

NADA 140-843 original approval
Sponsor: Hoechst Roussel Vet
Generic Name: narasin, bambermycins, roxarsone
Trade Name: Monteban®, Flavomycin®, 3-Nitro®
Indications for Use: To prevent coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain, improved feed efficiency, and improved pigmentation in broiler chickens.
Date of Approval: December 23, 1997

NADA 140-844 original approval
Sponsor: American Cyanamid Co.
Generic Name: levamisole
Trade Name: TRAMISOL®
Indications for Use: TRAMISOL levamisole Pour-On is a broad spectrum anthelmintic which is effective against the following nematode infections in cattle when used in accordance with label directions: stomach worms, intestinal worms, and lungworms.
Date of Approval: January 21, 1988

NADA 140-845 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: bambermycins, narasin
Trade Name: Flavomycin, Monteban
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by susceptible organisms and for increased rate of weight gain and for improved feed efficiency in broiler chickens.
Date of Approval: February 7, 1989

NADA 140-846 original approval
Sponsor: Wildlife Laboratories, Inc.
Generic Name: melatonin implant
Trade Name: PRIME-X
Indications for Use: PRIME-X is recommended for use in healthy male and female kit and adult female mink selected for accelerated priming: PRIME-X implanted mink complete autumn molt and prime 4-6 weeks earlier than normal.
Date of Approval: June 21, 1994

NADA 140-847 original approval
Sponsor: Altana Inc.
Generic Name: nystatin, neomycin sulfate, thiostrepton, triamcinolone acetonide ointment
Trade Name: Animax Ointment
Indications for Use: Animax Ointment (nystatin, neomycin sulfate, thiostrepton, triamcinolone acetonide ointment) is particularly useful in the treatment of acute and chronic otitis of varied etiologies, in interdigital cysts in cats and dogs, and in anal gland infections in dogs. The preparation is also indicated in the management of dermatologic disorders characterized by inflammation and dry or exudative dermatitis, particularly those caused, complicated, or threatened by bacterial or candidal infections. It is also of value in eczematous dermatitis, contact dermatitis, and seborrheic dermatitis, and as an adjunct in the treatment of dermatitis due to parasitic infestation.
Date of Approval: September 30, 1988

NADA 140-848 original approval
Sponsor: Hoffman-La Roche Inc.
Generic Name: diazepam
Trade Name: Veteeze® Injection
Indications for Use: As a preanesthetic agent to reduce the amount barbiturate required for short duration anesthesia in dogs.
Date of Approval: December 17, 1992

NADA 140-850 original approval
Sponsor: Elite Chemical Corp., Inc.
Generic Name: dichlorophene-toluene worm capsules
Trade Name: Elite Dog & Cat Wormer, Elite Dog Wormer, Elite Cat Wormer
Indications for Use: For removal of ascarids and hookworms and as an aid in removal of tapeworms from dogs and cats.
Date of Approval: February 14, 1989

NADA 140-851 original approval
Sponsor: Hess & Clark, Inc.
Generic Name: 0.2% nitrofurazone dressing (water soluble) veterinary
Trade Name: NFZ Wound Dressing
Indications for Use: For the prevention or treatment of surface bacterial infections of wounds, burns, and cutaneous ulcers of dogs, cats and horses (not for food use).
Date of Approval: July 7, 1989

NADA 140-852 original approval
Sponsor: A. L. Laboratories, Inc.
Generic Name: narasin, roxarsone, bacitracin methylene disalicylate
Trade Name: Monteban®, 3-Nitro®, BMD®
Indications for Use: For the prevention of coccidiosis caused by susceptible organisms and for increased rate of weight gain and improved feed efficiency in broiler chickens.
Date of Approval: July 5, 1989

NADA 140-852 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: Narasin Bacitracin methylene disalicylate Roxarsone
Trade Name: Monteban®, 3-Nitro®, BMD®
Date of Approval: July 29, 1998

NADA 140-853 original approval
Sponsor: A. L. Laboratories, Inc.
Generic Name: bacitracin methylene disalicylate, narasin
Trade Name: BMD®, Monteban®
Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. mivati , and E. brunetti , for increased rate of weight gain, and for improved feed efficiency in broiler chickens.
Date of Approval: May 22, 1992

NADA 140-854 original approval
Sponsor: Syntex Animal Health, Inc.
Generic Name: oxfendazole
Trade Name: Synanthic®
Indications for Use: Oxfendazole is indicated for the treatment and control of: lungworms, stomach worms, and intestinal worms.
Date of Approval: September 17, 1990

NADA 140-854 supplemental approval
Sponsor: Fort Dodge Animal Health
Generic Name: Oxfendazole
Trade Name: SYNANTHIC (oxfendazole) Bovine Dewormer Suspension, 22.5%
Effect of Supplement: This supplement provides for a change in marketing status from prescription (Rx) to over-the-counter (OTC) by removing the intraruminal route of administration on the 22.5% suspension.
Date of Approval: January 29, 2007

NADA 140-856 supplemental approval
Sponsor: Intervet, Inc.
Generic Name: serum gonadotropin and chorionic gonadotropin for injection
Trade Name: P.G. 600 ®
Effect of Supplement: The original application provides for use of P.G.600 ® in prepuberal gilts. The supplement extends the conditions of use to include sows at weaning.
Date of Approval: August 30, 1993

NADA 140-857 original approval
Sponsor: Norden Laboratories, Inc.
Generic Name: luprostiol
Trade Name: Equestrolin™
Indications for Use: Indicated for 1) estrus control and 2) termination of pregnancy in mares.
Date of Approval: January 5, 1990

NADA 140-859 original approval
Sponsor: American Cyanamid Company
Generic Name: salinomycin sodium + chlortetracycline
Trade Name: BIO-COX® + AUREOMYCIN®
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by susceptible organisms and as an aid in the reduction of mortality due to E. coli infections susceptible to such treatment.
Date of Approval: June 13, 1989

NADA 140-863 original approval
Sponsor: Elanco Animal Health
Generic Name: Ractopamine hydrochloride
Trade Name: Paylean®
Indications for Use: For increased rate of weight gain, improved feed efficiency, and increased carcass leaness in finishing swine fed a complete ration containing at least 16% crude protein from 150lbs (68kg) to 240lb (109 kg) body weight.
Date of Approval: December 22, 1999

NADA 140-863 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: Ractopamine hydrochloride
Trade Name: Paylean®
Indications for Use: To amend cautionary language in product labeling
Date of Approval: June 6, 2002

NADA 140-863 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: Ractopamine hydrochloride
Trade Name: PAYLEAN 9 and PAYLEAN 45
Effect of Supplement: This supplement provides for the replacement of the current indication and dosage with a new indication that allows use in pigs weighing in excess of 240 lb and a new dose range of 4.5 to 9.0 grams per ton. Additionally, this supplement updates the caution statement to reflect new animal safety data.
Date of Approval: April 25, 2006

NADA 140-865 original approval
Sponsor: Roche Vitamins Inc.
Generic Name: Narasin, Bacitracin zinc
Trade Name: MONTEBAN®, BACIFERM
Indications for Use: For the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima. For increased rate of weight gain and improved feed efficiency in broiler chickens.
Date of Approval: August 7, 2000

NADA 140-865 supplemental approval
Sponsor: Alpharma Inc
Generic Name: Narasin, Bacitracin zinc
Trade Name: MONTEBAN®, ALBAC
Effect of Supplement: To provide for the addition of ALBAC® (bacitracin zinc) Type A Medicated article as an alternate source of bacitracin zinc for the approved combination of MONTEBAN® (narasin) and BACIFERM® (bacitracin zinc). No Federal Register required because there is no change to the CFR.
Date of Approval: April 29, 2002

NADA 140-866 original approval
Sponsor: VET-A-MIX, Inc.
Generic Name: yohimbine hydrochloride injectable solution
Trade Name: Yobine™Injectable Solution
Indications for Use: Xylazine Reversing Agent and Antidote For Use in Dogs Only
Date of Approval: September 26, 1989

NADA 140-867 original approval
Sponsor: American Cyanamid Company
Generic Name: salinomycin sodium + chlortetracycline + roxarsone
Trade Name: BIO-COX® + AUREOMYCIN® + 3-Nitro®
Indications for Use: For the prevention of coccidiosis in broiler chickens cause by susceptible organisms including some field strains of E. tenella that are more susceptible to roxarsone combined with salinomycin than salinomycin alone as an aid in the reduction of mortality due to E. coli infections susceptible to such treatment.
Date of Approval: June 12, 1989

NADA 140-869 original approval
Sponsor: Purina Mills, Inc.
Generic Name: medicated feed block containing 6.6% poloxalene
Trade Name: Purina Bloat Block
Indications for Use: For control of legume (alfalfa, clover) and wheat pasture bloat in cattle when consumed at the prescribed rate.
Date of Approval: August 8, 1989

NADA 140-872 original approval
Sponsor: Animal Sciences Division of Monsanto Company
Generic Name: Recombinant DNA-derived methionyl bovine somatotropin
Trade Name: POSILAC® (sterile sometribove zinc suspension)
Indications for Use: For increased production of marketable milk in lactating dairy cows.
Date of Approval: November 5, 1993

NADA 140-872 supplemental approval
Sponsor: Monsanto Company
Generic Name: Sometribove zinc suspension
Trade Name: Posilac 1 Step®
Effect of Supplement: A study was conducted to evaluate the effectiveness and animal safety of sometribove given by subcutaneous injection in the neck area.
Date of Approval: December 27, 2001

NADA 140-872 supplemental approval
Sponsor: Monsanto Company
Generic Name: Sometribove zinc suspension
Trade Name: Posilac 1 Step®
Effect of Supplement: This Freedom of Information Summary describes the basis for labeling changes to modify/remove precautions pertaining to target animal safety and reproduction.
Date of Approval: September 11, 2003

NADA 140-874 original approval
Sponsor: Wildlife Laboratories
Generic Name: yohimbine hydrochloride
Trade Name: Antagonil
Indications for Use: For the antagonism of xylazine sedation in free-ranging and confined members of the family Cervidae (deer and elk).
Date of Approval: February 3, 1993

NADA 140-879 original approval
Sponsor: Norden Laboratories
Generic Name: nystatin - neomycin sulfate - thiostrepton - triamcinolone - acetonide topical ointment
Trade Name: DERMA 4 Ointment
Indications for Use: DERMA 4 Ointment is particularly useful in the treatment of: (1) acute and chronic otitis of varied etiologies; (2) interdigital cysts in dogs and cat; (3) anal gland infections in dogs; (4) dermatologic disorders characterized by inflammation and dry or exudative dermatitis, particularly those caused, complicated, or threatened by bacterial or candidal (Candida albicans ) infection; and (5) eczematous, contact and seborrheic dermatitis. Additionally, DERMA 4 Ointment may be used as an adjunct in the treatment of dermatitis due to parasitic infestation.
Date of Approval: August 2, 1989

NADA 140-881 original approval
Sponsor: Biomed Laboratories
Generic Name: nitrofurazone soluble dressing
Trade Name: Nitrofurazone Soluble Dressing
Indications for Use: For the prevention or treatment of surface bacterial infections of wounds, burns and cutaneous ulcers of dogs, cats and horses (not for food use).
Date of Approval: May 11, 1990

NADA 140-883 original approval
Sponsor: MOBAY Corporation
Generic Name: Hyaluronate Sodium
Trade Name: Legend(TM) ™(Hyaluronate Sodium) Injectable Solution
Indications for Use: Legend Injectable Solution is indicated in the treatment of joint dysfunction of the carpus or fetlock in horses due to non-infectious synovitis associated with equine osteoarthritis.
Date of Approval: September 12, 1991

NADA 140-883 supplemental approval
Sponsor: Bayer HealthCare LLC
Generic Name: Hyaluronate sodium
Trade Name: LEGEND Multi Dose Injectable Solution
Effect of Supplement: Approval of the supplement will add a multiple dose vial containing the preservative benzyl alcohol.
Date of Approval: December 15, 2005

NADA 140-886 original approval
Sponsor: Merck Sharp & Dohme Research Laboratories
Generic Name: ivermectin
Trade Name: HEARTGARD-30 Chewables
Indications for Use: For use in dogs to prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis ) up to a month after infection.
Date of Approval: July 3, 1989

NADA 140-889 original approval
Sponsor: A.H. ROBINS and Biocraft Laboratories, Inc.
Generic Name: nystatin, neomycin sulfate, thiostrepton, triamcinolone, acetonide ointment
Trade Name: Derm-Otic Ointment
Indications for Use: Derm-Otic Ointment (nystatin, neomycin sulfate, thiostrepton, triamcinolone acetonide ointment) is particularly useful in the treatment of acute and chronic otitis of varied etiologies, in interdigital cysts in cats and dogs, and in anal gland infections in dogs. The preparation is also indicated in the management of dermatologic disorders characterized by inflammation and dry or exudative dermatitis, particularly those caused, complicated, or threatened by bacterial or candidal (Candida albicans ) infections. It is also of value in eczematous dermatitis, and as an adjunct in the treatment of dermatitis due
to parasitic infestation.
Date of Approval: November 21, 1989

NADA 140-890 original approval
Sponsor: The Upjohn Company
Generic Name: ceftiofur hydrochloride sterile suspension
Trade Name: EXCENEL® Sterile Suspension*
Indications for Use: EXCENEL® Sterile Suspension is indicated for the treatment/control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis and Streptococcus suis Type 2.
Date of Approval: April 26, 1996

NADA 140-890 supplemental approval
Sponsor: Pharmacia & Upjohn Co
Generic Name: Ceftiofur hydrochloride
Trade Name: Excencel® Sterile Suspension
Effect of Supplement: The supplemental application dated 7/26/98 provides for the use of an intramuscular or subcutaneous route of administration for Excenel® Sterile Suspension in new species cattle. The application dated 08/18/98 provides a revised label warning statement against use in veal calves.
Date of Approval: July 26, 1998; August 18, 1998

NADA 140-890 supplemental approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: ceftiofur hydrochloride
Trade Name: EXCENEL® RTU Sterile Suspension
Effect of Supplement: This supplement provides a new indication, within the currently approved dose and duration, for use of ceftiofur hydrochloride sterile suspension (EXCENEL® RTU Sterile Suspension) in cattle, for the treatment of acute metritis (0-14 days post-partum) associated with bacterial organisms susceptible to ceftiofur.
Date of Approval: February 8, 2002

NADA 140-890 supplemental approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: ceftiofur hydrochloride
Trade Name: EXCENEL® RTU Sterile Suspension
Effect of Supplement: To make the following four changes to the product insert:
1. revise the current "Microbiology" section to a "Clinical Microbiology" section
2. revise the minimum inhibitory concentration (MIC) table to include new MIC data for ceftiofur
3. add a table listing acceptable quality control ranges for ceftiofur
4. revise the National Committee for Clinical Laboratory Standards reference at the end to the insert.
Date of Approval: December 12, 2003

NADA 140-890 supplemental approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: ceftiofur hydrochloride
Trade Name: EXCENEL RTU Sterile Suspension
Effect of Supplement: For the treatment and control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis type 2.
Date of Approval: June 18, 2004

NADA 140-890 supplemental approval
Sponsor: Pharmacia & Upjohn Co.
Generic Name: Ceftiofur hydrochloride
Trade Name: EXCENEL RTU Sterile Suspension
Effect of Supplement: To establish a 3-day pre-slaughter withdrawal period for cattle
Date of Approval: June 2, 2006

NADA 140-892 original approval
Sponsor: Syntex Animal Health
Generic Name: oxfendazole
Trade Name: Synanthic® Bovine Dewormer Paste, 18.5%
Indications for Use: Oxfendazole is indicated for use in cattle (excluding female dairy cattle of breeding age) for the removal and control of: Lungworms, Stomach  worms: Barberpole worms, Brown stomach worms, Small stomach worms Intestinal worms: hookworms, small intestinal worm, tapeworms, nodular worms.
Date of Approval: June 29, 1993

NADA 140-893 original approval
Sponsor: Beecham Laboratories
Generic Name: Epsiprantel
Trade Name: CESTEX®
Indications for Use: CESTEX® (epsiprantel) tablets are indicated for the removal of the following: Feline cestodes:Dipylidium caninumand Taenia taeniaeformis.Canine cestodes:Dipylidium caninumand Taenia pisiformis
Date of Approval: December 1, 1989

NADA 140-896 (INAD 4521) original approval
Sponsor: Schering-Plough Animal Health Corporation
Generic Name: Gentamicin sulfate, clotrimazole, and betamethasone valerate
Trade Name: OTOMAX®
Indications for Use: OTOMAX is indicated for treatment of canine acute and chronic otitis externa associated with yeast (Malassezia pachydermatisformerly Pityrosporum canis) and/or bacteria susceptible to gentamicin.
Date of Approval: June 9, 1993

NADA 140-897 original approval
Sponsor: Roussel UCLAF
Generic Name: trenbolone acetate and estradiol
Trade Name: REVALOR®-S
Indications for Use: For increased rate of weight gain and improved feed efficiency in feedlot steers.
Date of Approval: November 27, 1991

NADA 140-897 supplemental approval
Sponsor: Roussel Uclaf
Generic Name: trenbolone acetate and estradiol
Trade Name: REVALOR®-G
Effect of Supplement: Provides for the administration of REVALOR®-G in pasture steers (slaughter, stocker and feeder steers) for increased rate of weight gain.
Date of Approval: March 27, 1996

NADA 140-897 supplemental approval
Sponsor: Roussel Uclaf
Generic Name: trenbolone acetate and estradiol
Trade Name: REVALOR®-G
Effect of Supplement: Provides for the administration of REVALOR®-G in pasture heifers (slaughter, stocker and feeder heifers) for increased rate of weight gain.
Date of Approval: July 2, 1996

NADA 140-897 supplemental approval
Sponsor: Hoechst Roussel Vet
Generic Name: trenbolone acetate and estradiol
Trade Name: REVALOR®-IS
Effect of Supplement: Provides for the use of an additional dose ear implant for steers fed in confinement for slaughter for increased rate of weight gain and improved feed efficiency.
Date of Approval: June 19, 2000

NADA 140-897 supplemental approval
Sponsor: Intervet, Inc.
Generic Name: Trenbolone Acetate and Estradiol
Trade Name: REVALOR–S, REVALOR-IS, REVALOR-G
Effect of Supplement: This supplement provides for addition to the labeling of the statements “A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.” to the warning section and “Do not use in veal calves. Effectiveness and animal safety in veal calves have not been established.” immediately following the label indications.
Date of Approval: October 28, 2004

NADA 140-901 original approval
Sponsor: Luitpold Pharmaceuticals, Inc.
Generic Name: Polysulfated Glycosaminoglycan (PSGAG)
Trade Name: Adequan® i.m.
Indications for Use: Adequan® i.m. is recommended for the intramuscular treatment of noninfectious degenerative and/or traumatic joint dysfunction and associated lameness of the carpal joint in horses.
Date of Approval: November 11, 1989

NADA 140-901 supplemental approval
Sponsor: Luitpold Pharmaceuticals, Inc.
Generic Name: Polysulfated Glycosaminoglycan (PSGAG)
Trade Name: Adequan® i.m
Effect of Supplement: Effect of Supplement: This supplemental application amends the NADA to provide for the use of Adequan® i.m. in the treatment of noninfectious degenerative and/or traumatic joint dysfunction and associated lameness of the hock joint in horses.
Date of Approval: September 12, 1996

NADA 140-904 original approval
Sponsor: Veterinary Research and Development, Inc.
Generic Name: copper disodium edetate
Trade Name: Bovi-Cu
Indications for Use: For use in beef cattle and beef calves to prevent copper deficiency alone on or in association with molybdenum toxicity.
Date of Approval: April 18, 1989

NADA 140-908 original approval
Sponsor: Lloyd, Inc.
Generic Name: Sulfamethazine USP
Trade Name: Veta-Meth™ (sulfamethazine)
Indications for Use: For the treatment of diseases caused by organisms sensitive to sulfamethazine such as bacterial pneumonia and bovine respiratory disease complex (shipping fever complex) ...
Date of Approval: September 16, 1999

NADA 140-909 original approval
Sponsor: Norden Laboratories, Inc.
Generic Name: sulfamethazine bolus
Trade Name: Sulka-S ™Bolus
Indications for Use: For treatment of the following diseases caused by organisms susceptible to sulfamethazine: bacterial scours (colibacillosis) caused by Escherichia coli , necrotic pododermatitis (foot rot) and calf diphtheria caused by Fusobacterium necrophorum , bacterial pneumonia associated with Pasteurella spp. , and coccidiosis caused by Eimeria bovis and E. zurnii in ruminating beef and dairy calves.
Date of Approval: March 27, 1989

NADA 140-910 original approval
Sponsor: HESS & CLARK, INC.
Generic Name: nitrofurazone soluble powder
Trade Name: NFZ Wound powder
Indications for Use: For the prevention or treatment of surface bacterial infections of wounds, burns, skin ulcers and abscesses after incision. For use only on dogs, cats and horses (not for food use).
Date of Approval: July 17, 1989

140-912 original approval
Sponsor: Mobay Corporation
Generic Name: febantel
Trade Name: Rintal® Tabs Anthelmintic Tablets
Indications for Use: Rintal® Tabs Anthelmintic Tablets are indicated for the removal of the following nematode parasites: In Dogs and Puppies: Hookworms (Ancylosotoma caninum, Uncinaria stenocephala); Ascarids (Toxocara canis, Toxascaris leonina); Whipworms (Trichuris vulpis). In Cats and Kittens: Hookworms (ancylostoma tubaeforme); Ascarids (Toxocara cati).
Date of Approval: July 19, 1991

NADA 140-913 original approval
Sponsor: Mobay Corporation
Generic Name: Enrofloxacin
Trade Name: Baytril® Antibacterial Injectable Solution
Indications for Use: Baytril® (brand of enrofloxacin) Antibacterial Tablets and Injectable Solution are indicated for the treatment of the following bacterial infections in dogs:Dermal infections (wounds and abscesses) caused by susceptible strains of Escherichia coli, Klebsiella pneumoniae *, Proteus mirabilis, and Staphylococcus aureus; Respiratory infections (pneumonia, tonsillitis, rhinitis) caused by susceptible strains of Escherichia coliand Staphylococcus aureus. Urinary cystitis caused by susceptible strains of Escherichia coli, Proteus mirabilis and Staphylococcus aureus.
Date of Approval: May 4, 1990

NADA 140-913 supplemental approval
Sponsor: Bayer Corporation
Generic Name: enrofloxacin tablets and enrofloxacin injectable solution
Trade Name: Baytril® Antibacterial Tablets and Baytril® Antibacterial Injectable Solution
Effect of Supplement: Revises dosage frequency, indications, and limitations.
Date of Approval: June 18, 1997

NADA 140-915 original approval
Sponsor: Ciba-Geigy Animal Health
Generic Name: milbemycin oxime tablets
Trade Name: INTERCEPTOR®
Indications for Use: Interceptor tablets are indicated for use in the prevention of heartworm disease caused by Dirofilaria immitis and control of adult hookworm infections caused by Ancylostoma caninum in dogs.
Date of Approval: June 14, 1990

NADA 140-915 supplemental approval
Sponsor: CIBA-GEIGY Animal Health
Generic Name: milbemycin oxime tablets
Trade Name: INTERCEPTOR®
Effect of Supplement: Approval of the supplemental NADA will change NADA No. 140-915 by adding indications for the removal and control of adult Toxocara canis (roundworm) and Trichuris vulpis (whipworm) infections in dogs over eight weeks of age. Data supporting efficacy for the roundworm and whipworm indications is contained in this supplemental NADA. The supplemental application does not propose any changes in the formulation, dosage forms, manufacturing procedures, recommended dosages or treatment regiment for INTERCEPTOR (milbemycin oxime)
Date of Approval: December 29, 1992

NADA 140-915 supplemental approval
Sponsor: Ciba-Geigy Corporation
Generic Name: milbemycin oxime tablets
Trade Name: INTERCEPTOR Flavor Tabs
Effect of Supplement: Approval of the supplemental NADA will change NADA No. 140-915 by adding indications for the use of INTERCEPTOR (milbemycin oxime) Flavor Tabs in puppies four weeks of age or greater and two pounds of body weight or greater (from greater than eight weeks of age). The supplemental application does not propose any changes in the formulation, dosage forms, manufacturing procedures, recommended dosages or monthly treatment regimen for INTERCEPTOR (milbemycin oxime) Flavor Tabs.
Date of Approval: August 16, 1995

NADA 140-915 supplemental approval
Sponsor: Ciba-Geigy Corporation
Generic Name: Milbemycin Oxime Tablets
Trade Name: Interceptor®
Effect of Supplement: This supplement expands the indications to include the removal and control of adult roundworms Toxascaris leonina. Laboratory data support the efficacy of the drug against this species.
Date of Approval: Sep. 9, 1996

NADA 140-915 supplemental approval
Sponsor: Novartis Animal Health
Generic Name: milbemycin oxime
Trade Name: INTERCEPTOR® FLAVOR TABS® for cats
Effect of Supplement: Approval of this supplemental NADA will change NADA 140-915 by adding an additional species (cat) to the label. The supplemental application also provides for changes in the dosage and indications for the cat only. No changes are made in the dosage form, dosages or treatment regimen for the dog. The cat will have labeling separate from the dog approval.
Date of Approval: March 10, 1998

NADA 140-915 supplemental approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Milbemycin Oxime Tablets
Trade Name: Safeheart™
Effect of Supplement: For the prevention of heartworm disease caused by Dirofilaria immitis in dogs and puppies four weeks of age or greater and 2 pounds of body weight or greater.
Date of Approval: June 4, 1998

NADA 140-916 original approval
Sponsor: Fermenta Animal Health Company
Generic Name: tiamulin
Trade Name: DENAGARD® Liquid Concentrate
Indications for Use: For the treatment of swine dysentery associated with Treponema hyodysenteriae and swine pneumonia due to Actinobacillus pleuropneumoniae susceptible to tiamulin.
Date of Approval: Jan 29, 1993

NADA 140-918 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: halofuginone hydrobromide, bambermycins
Trade Name: Stenorol®, Flavomycin®
Indications for Use: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gain in growing turkeys.
Date of Approval: March 22, 1996

NADA 140-919 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: halofuginone hydrobromide; bacitracin methylene disalicylate
Trade Name: Stenorol®, BMD®
Indications for Use: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagimitis, and E. gallopavonis; and for increased rate of weight gain in growing turkeys.
Date of Approval: Jan 29, 1993