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RULES: Flunixin,
Published: 2006-03-31
The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of an abbreviated new animal drug
application (ANADA) filed by Cross Vetpharm Group Ltd. The ANADA
provides for the veterinary prescription use of flunixin meglumine
injectable solution for the control of inflammation in horses and
cattle.
RULES: Oxytetracycline; implantation or injectable dosage form,
Published: 2006-06-06
The Food and Drug Administration (FDA) is amending the animal
drug regulations to correct the indications for use for the 200
milligram (mg)/milliliter (mL) strength of oxytetracycline injectable
solution used in beef cattle for the treatment and control of various
bacterial diseases. This action is being taken to improve the accuracy
of the
RULES: Trimethoprim and sulfadiazine injectable suspension,
Published: 2006-05-31
The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by ScheringPlough Animal Health Corp. The supplemental NADA provides for
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revised food safety labeling for trimethoprim and sulfadiazine
injectable suspension, administered to
RULES: Hyaluronate sodium injection,
Published: 2006-07-12
The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Pharmacia & Upjohn Co., a Division of
Pfizer, Inc. The supplemental NADA provides for a revised food safety
warning on labeling for hyaluronate sodium injectable solution.
RULES: Mepivacaine,
Published: 2006-07-13
The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Pharmacia & Upjohn Co. The supplemental
NADA provides for revised food safety labeling for mepivacaine
injectable solution used in horses for local anesthesia.
RULES: Glycopyrrolate,
Published: 2006-11-02
The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of an abbreviated new animal drug
application (ANADA) filed by IVX Animal Health, Inc. The ANADA provides
for veterinary prescription use of glycopyrrolate solution as an
injectable preanesthetic agent in dogs and cats.
RULES: Furosemide,
Published: 2006-07-13
The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Intervet Inc. The supplemental NADA
provides for the revision of a food safety warning on labeling of
furosemide injectable solution for use in horses.
RULES: Lincomycin; Correction,
Published: 2006-11-07
The Food and Drug Administration (FDA) is correcting a
document amending the animal drug regulations to reflect approval of an
abbreviated new animal drug application (ANADA) that appeared in the
Federal Register of September 1, 2006 (71 FR 51995). FDA is correcting
the date of approval of an ANADA for a generic lincomycin injectable
solution
RULES: Lincomycin,
Published: 2006-09-01
The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of an abbreviated new animal drug
application (ANADA) filed by Cross Vetpharm Group Ltd. The ANADA
provides for the use of lincomycin injectable solution in swine for the
treatment of infectious arthritis and mycoplasma pneumonia.
RULES: Hyaluronate sodium solution,
Published: 2006-01-11
The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Bayer HealthCare LLC. The supplemental NADA
provides for veterinary prescription use of a hyaluronate sodium
solution, formulated with a benzyl alcohol preservative, for
intravenous
RULES: Tulathromycin,
Published: 2006-09-29
The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Pfizer, Inc. The supplemental NADA provides
for the addition of a pathogen to the indication for use of
tulathromycin in cattle, by injection, for the treatment of respiratory
disease.
RULES: Moxidectin solution,
Published: 2006-02-13
The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Fort Dodge Animal Health. The supplemental
NADA provides for use of an injectable moxidectin solution in cattle
for the treatment and control of an additional three species of
internal
RULES: Gentamicin,
Published: 2006-12-22
The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of an abbreviated new animal drug
application (ANADA) filed by Sparhawk Laboratories, Inc. The ANADA
provides for use of a gentamicin sulfate injectable solution in piglets
for treatment of porcine colibacillosis.
RULES: Estradiol benzoate; implantation or injectable dosage form,
Published: 2006-02-17
The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by PR Pharmaceuticals, Inc. The supplemental
NADA provides for subcutaneous injection, in the ear only, of a
suspension implant of estradiol benzoate microspheres for increased
rate of weight
RULES: Flunixin,
Published: 2006-03-29
The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental abbreviated new
animal drug application (ANADA) filed by Norbrook Laboratories, Ltd.
The supplemental ANADA provides for the veterinary prescription use of
flunixin meglumine solution by intravenous injection in lactating dairy