Search Results: CFR:21 CFR Part 522

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1. Implantation or Injectable Dosage Form New Animal Drugs; Flunixin

RULES: Flunixin,

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.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

2. Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline Injection, 200 Milligram/Milliliter

RULES: Oxytetracycline; implantation or injectable dosage form,

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
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

3. Implantation or Injectable Dosage Form New Animal Drugs; Trimethoprim and Sulfadiazine

RULES: Trimethoprim and sulfadiazine injectable suspension,

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
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

4. Implantation or Injectable Dosage Form New Animal Drugs; Hyaluronate Sodium Injection

RULES: Hyaluronate sodium injection,

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.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

5. Implantation or Injectable Dosage Form New Animal Drugs; Mepivacaine

RULES: Mepivacaine,

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.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

6. Implantation or Injectable Dosage Form New Animal Drugs; Glycopyrrolate

RULES: Glycopyrrolate,

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.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

7. Implantation or Injectable Dosage Form New Animal Drugs; Furosemide

RULES: Furosemide,

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.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

8. Implantation or Injectable Dosage Form New Animal Drugs; Lincomycin; Correction

RULES: Lincomycin; Correction,

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
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

9. Implantation or Injectable Dosage Form New Animal Drugs; Lincomycin

RULES: Lincomycin,

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.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

10. Implantation or Injectable Dosage Form New Animal Drugs; Hyaluronate Sodium Injection

RULES: Hyaluronate sodium solution,

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
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

11. Implantation or Injectable Dosage Form New Animal Drugs; Tulathromycin

RULES: Tulathromycin,

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.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

12. Implantation or Injectable Dosage Form New Animal Drugs; Moxidectin Solution

RULES: Moxidectin solution,

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
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

13. Implantation or Injectable Dosage Form New Animal Drugs; Gentamicin

RULES: Gentamicin,

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.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

14. Implantation or Injectable Dosage Form New Animal Drugs; Estradiol Benzoate

RULES: Estradiol benzoate; implantation or injectable dosage form,

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
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

15. Implantation or Injectable Dosage Form New Animal Drugs; Flunixin

RULES: Flunixin,

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
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
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