FOI Documents 140-000 - 149-999
Listed with Abstracts from the Summaries
NADA 140-008 original approval
Sponsor: Miles Inc.
Generic Name: praziquantel + pyrantel pamoate
Trade Name: Drontal™ Tablets
Indications for use: Drontal Tablets will remove Tapeworms
(Dipylidium caninum, Taenia taeniaeformis ), Hookworms
(Ancylostoma tubaeforme ) and Large Roundworms (Toxocara
cati ) in kittens and cats.
Date of Approval: September 29, 1993
NADA 140-011 original approval
Sponsor: Fermenta Animal Health Company
Generic Name: tiamulin hydrogen fumarate + chlortetracycline
(equivalent to chlortetracycline hydrochloride)
Trade Name: Denagard® 10; chlortetracycline premixes
Indications for use: For the control of swine dysentery
associated with Serpulina hyodysenteriae susceptible
to tiamulin and for treatment of swine bacterial enteritis caused
by Escherichia coli and Salmonella choleraesuis
sensitive to chlortetracycline and treatment of bacterial pneumonia
caused by Pasteurella multocida sensitive to chlortetracycline.
Date of Approval: August 20, 1996
NADA
140-269 original approval
Sponsor: Fort Dodge Laboratories
Generic Name: ketoprofen
Trade Name: Ketofen™
Indications for use: Ketofen(TM) is indicated for the
alleviation of inflammation and pain associated with musculoskeletal
disorders in the horse.
Date of Approval: September 26, 1990
NADA 140-270 original approval
Sponsor: Medico Industries, Inc.
Generic Name:sulfamethazine
Trade Name: Sulfamethazine Sustained Release Bolus
Indications for use: Sulfamethazine Sustained Release
Bolus is indicated for the treatment of the following diseases
in beef cattle and non-lactating dairy cattle: Bovine respiratory
disease complex (shipping fever complex) associated with Pasteurella
spp.; bacterial pneumonia associated with Pasteurella
spp.; necrotic pododermatitis (foot rot) and calf diphtheria
caused by Fusobacterium necrophorum; colibacillosis (bacterial
scours) caused by Escherichia coli; coccidiosis caused
by Eimeria bovis and E. zurnii; acute mastitis
and metritis caused by Streptococcus spp.
Date of Approval: August 25, 1986
NADA 140-288 supplemental
approval
Sponsor: The Upjohn Company
Generic Name: melengestrol acetate, lasalocid, tylosin
Trade Name: MGA®100/200 Premix, MGA®500 Liquid
Premix, BOVATEC®, TYLAN®
Effect of Supplement: This supplement provides for removal
of the requirement of a pre-slaughter drug withdrawal period
for heifers fed melengestrol acetate when melengestrol acetate
is fed in combination either with lasalocid or with lasalocid
and tylosin.
Date of Approval: June 29, 1994
NADA 140-338 original approval
Sponsor: The Upjohn Company
Generic Name: ceftiofur sodium sterile powder
Trade Name: Naxcel Sterile Powder
Indications for use: Naxcel Sterile Powder is indicated
for treatment of bovine respiratory disease (shipping fever,
pneumonia).
Date of Approval: January 25, 1988
NADA 140-338 supplemental
approval
Sponsor: The Upjohn Company
Generic Name: ceftiofur sodium sterile powder
Trade Name: Naxcel Sterile Powder
Effect of Supplement:This supplemental application provides
for a change in the approved dosage of 0.5 mg/lb body weight
to a range of 0.5 mg to 1.0 mg ceftiofur sodium/lb of body weight.
Date of Approval: April 5, 1990
NADA 140-338 supplemental
approval
Sponsor: The Upjohn Company
Generic Name: ceftiofur sodium
Trade Name: NAXCELR® Sterile Powder
Effect of Supplement: Provides for the use of ceftiofur
sodium (NAXCEL Sterile Powder) in lactating dairy cattle, a
new class of animal, for the same indications approved in the
parent NADA.
Date of Approval: March 15, 1991
NADA 140-338 supplemental
approval
Sponsor: The Upjohn Company
Generic Name: ceftiofur sodium sterile powder
Trade Name: NAXCEL® Sterile Powder
Effect of Supplement: This supplement provides for an
additional species, swine, to be added to the previously approved
product, NAXCEL®
Date of Approval: August 4, 1992
NADA 140-338 supplemental
approval
Sponsor: The Upjohn Company
Generic Name: ceftiofur sodium
Trade Name: NAXCEL® Sterile Powder
Effect of Supplement: The supplement provides data in
support of a request for approval of Naxcel ® Sterile Powder
for an additional species (equine). The issue of the Freedom
of Information (FOI) Summary should be considered an extension
of previously approved version describing data in support of
Naxcelreg., NADA 140-338, approved as a treatment for respiratory
disease in cattle January 25, 1988.
Date of Approval: July 13, 1994
NADA 140-338
supplemental approval
Sponsor: The Upjohn Company
Generic Name: ceftiofur sodium sterile powder
Trade Name: NAXCEL® Sterile Powder
Effect of Supplement:Provides for the use of ceftiofur
sodium (NAXCEL® Sterile Powder) in cattle for a new indication.
Date of Approval: August 24, 1995
NADA 140-338
supplemental approval
Sponsor: The Upjohn Company
Generic Name: Ceftiofur sodium
Trade Name: NAXCEL® Sterile Powder
Effect of Supplement:Provides for an additional species,
day-old turkey poults, to be added to the previously approved
product, NAXCEL® Sterile Powder; also provides for revision
of the chick indication.
Date of Approval: May 21, 1996
NADA 140-338 supplemental
approval
Sponsor: Pharmacia & Upjohn
Generic Name: ceftiofur sodium
Trade Name: Naxcel® Sterile Powder
Effect of Supplement: The approval of this supplement
will allow for the use of ceftiofur sodium (NAXCEL Sterile Powder)
for the treatment of bacterial pneumonia in sheep.
Date of Approval: October 25, 1996
NADA 140-338 supplemental
approval
Sponsor: Pharmacia & Upjohn
Generic Name: ceftiofur sodium
Trade Name: Naxcel® Sterile Powder
Date of Approval: March 7, 2001
NADA 140-338 supplemental
approval
Sponsor: Pharmacia & Upjohn
Generic Name: ceftiofur sodium sterile powder
Trade Name: NAXCEL® brand of ceftiofur sodium sterile
powder.
Effect of Supplement: Provides for the use of a subcutaneous
(SC) route of administration for NAXCEL® Sterile Powder
in cattle.
Date of Approval: May 29, 2001
NADA 140-338 supplemental approval
Sponsor: Pharmacia & Upjohn
Generic Name: ceftiofur sodium
Trade Name: NAXCEL Sterile Powder
Effect of Supplement: This supplement provides four specific
changes to
the product insert, 1) revision of the “clinical microbiology”
section to update the MIC table using the new MIC data for ceftiofur,
2) the addition of a table listing acceptable quality control
ranges for ceftiofur, 3) the addition of the latest National
Committee for Clinical Laboratory Standards (NCCLS) reference
at the end of the insert, and 4) clarification of the statement
under “Storage Conditions” dealing with the storage
of reconstituted Naxcel via freezing.
Date of Approval: December 31, 2003
NADA
140-338 supplemental approval
Sponsor: Pharmacia & Upjohn
Generic Name: ceftiofur sodium
Trade Name: NAXCEL Sterile Powder
Effect of Supplement:This supplement updates survey microbiological
data and adds the National Committee for Clinical Laboratory
Standards’ (NCCLS) interpretive criteria for equine isolates
to the NAXCEL Sterile Powder package insert.
Date of Approval: February 27, 2004
NADA 140-338 supplemental approval
Sponsor: Pharmacia & Upjohn Co.
Generic Name: Ceftiofur sodium
Trade Name: NaxcelŽ
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 140-339 original approval
Sponsor: Hoechst Roussel Vet
Generic Name: Nicarbazin, bambermycins
Trade Name: Nicarb®, Flavomycin®
Indications for use: As an aid in preventing outbreaks
of cecal coccidiosis caused by Eimeria tenella, intestinal
coccidiosis caused by E. acervulina, E. maxima, E. nectarix,
and E. brunetti,, increased rate of weight gain and improved
feed efficiency.
Date of Approval: August 6, 1999
NADA 140-340 original approval
Sponsor: Roussel-Uclaf
Generic Names: lincomycin, halofuginone hydrobromide
Trade Names: Lincomix®, Stenorol®
Indications for use: For the prevention of coccidiosis
caused by E. tenella, E. necatrix, E. acervulina, E. maxima,
E. mivati, and E. brunetti; and for improved feed
efficiency in broiler chickens.
Date of Approval: March 21, 1989
NADA 140-439 original approval
Sponsor: Merck Sharp & Dohme Research Laboratories
Generic Name: ivermectin
Trade Name: EQVALAN Liquid
Indications for use: For treatment and control of the
following parasites or parasitic conditions in horses: bots,
large mouth stomach worms, neck threadworms, pinworms, ascarids,
lungworms, intestinal threadworms, small strongyles large strongyles,
summer sores, and dermatitis caused by neck threadworm microfilariae.
Date of Approval: July 1, 1987
NADA 140-439 supplemental
approval
Sponsor: Merial Ltd.
Generic Name: ivermectin
Trade Name: EQVALAN Liquid For Horses
Effect of Supplement: This supplement amends the EQVALAN
(ivermectin) Oral Liquid For Horses labeling to add four species
of internal parasites and to reflect a change in the Indications
section which separates the listing of adult small strongyle
species from their related fourth-stage larvae. Specifically,
the supplement provides for the use of ivermectin oral liquid
for the treatment and control of Craterostomum acuticaudatum,
Petrovinema poculatum, and Coronocyclus spp.
including Coronocyclus coronatus and Coronocyclus
labratus. In addition, under the sub-heading Small Strongyles,
the labeling has been revised to separate the listing of adult
species from their related fourth-stage larvae.
Date of Approval: August 9, 2004
NADA 140-441 original approval
Sponsor: Mobay Corporation
Generic Name: enrofloxacin
Trade Name: Baytril® Antibacterial Tablets
Indications for use: For the treatment of dermal infections,
respiratory infections, and urinary cystitis caused by susceptible
strains of bacteria in dogs.
Date of Approval: December 27, 1988
NADA 140-441 supplemental
approval
Sponsor: Mobay Corporation
Generic Name: enrofloxacin
Trade Name: Baytril® Antibacterial Tablets
Effect of Supplement: This supplemental application amends
the NADA to remove the contradiction against use in breeding
female dogs.
Date of Approval: June 6, 1990
NADA 140-441 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 19, 1997
NADA 140-441 supplemental
approval
Sponsor: Bayer Corp., Agriculture Division, Animal Health
Division
Generic Name: enrofloxacin
Trade Name: Baytril® Taste Tabs™ Antibacterial
Tablets
Effect of Supplement: For the management of diseases
in dogs and cats associated with bacteria susceptible to enrofloxacin.
Date of Approval: August 3, 1999
NADA 140-442 original approval
Sponsor: Med-Tech, Inc.
Generic Name: xylaxine HCl
Trade Name: Xylazine HCl Injection
Indications for use: Xylazine HCl Injection should be
used in horses when it is desirable to produce a state of sedation.
It has been successfully used when conducting various diagnostic,
orthopedic and dental procedures and for minor surgical procedures
of short duration. It may also be used as a preanesthetic to
local or general anesthesia.
Date of Approval: February 18, 1988
NADA 140-443 original approval
Sponsor: Arkansas Micro Specialties, Inc.
Generic Name: hygromycin B
Trade Name: Hygromix 0.6 and 1.6 Premixes
Indications for use: SWINE: Control of infestations of
large roundworms (Ascaris suis), nodular worms (Oesophagostomum
dentatum) and whipworms (Trichuris suis). CHICKENS:
Control of infestations of large roundworms (Ascaris galli),
cecal worms (Heterakis gallinae), and capillary worms
(Capillaria obsignata). Discontinue swine feeds containing
hygromycin B 15 days before slaughter. Discontinue chicken feeds
containing hygromycin B 3 days before slaughter.
Date of Approval: May 30, 1986
NADA 140-445 original approval
Sponsor: Elanco Products Company
Generic Name: narasin + roxarsone (3-nitro-4-hydroxyphenylarsonic
acid)
Trade Name: Monteban® + Roxarsone
Indications for use: For the prevention of coccidiosis
in broiler chickens caused by bacteria that are more susceptible
to roxarsone combined with narasin than to narasin alone.
Date of Approval: June 28, 1988
NADA 140-448 original approval
Sponsor: Roussel-Uclaf
Generic Name: oxytetracycline + salinomycin sodium
Trade Name: Terramycin + Bio-Cox
Indications for use: As an aid in the reduction of mortality
due to air sacculitis (air sac infection) caused by Escherichia
coli sensitive to oxytetracycline and for the prevention
of coccidiosis caused by Eimeria necatrix, E. tenella, E.
acervulina, E. brunetti, E. mivati and E. maxima .
Date of Approval: April 13, 1990
NADA 140-474 original approval
Sponsor: Sterivet Laboratories Limited
Generic Name: hyaluronate sodium
Trade Name: Synacid™
Indications for use: For the treatment of equine carpal
and fetlock joint dysfunction caused by traumatic and/or degenerative
joint disease of mile to moderate severity.
Date of Approval: June 1, 1988
NADA 140-530 original approval
Sponsor: Agri-Basics
Generic Name: tylosin (as tylosin phosphate) combined
with sulfamethazine
Trade Name: Tylan 5, 10, 20 & 40 Sulfa-G
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: June 3, 1986
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 tootetracycline.
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 dermati
