Search Results: CFR:21 CFR Part 522

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

RULES: Boldenone,

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
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revised labeling for the veterinary prescription use of injectable boldenone solution in horses.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

2. Implantation or Injectable Dosage Form New Animal Drugs; Penicillin G Benzathine and Penicillin G Procaine Sterile

RULES: Penicillin G benzathine and procaine sterile 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 Cross Vetpharm Group Ltd. The supplemental NADA provides for the addition of
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statements to labeling of an injectable penicillin suspension warning against the use of this
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

3. Implantation or Injectable Dosage Form New Animal Drugs; Embutramide, Chloroquine, and Lidocaine Solution

RULES: Embutramide, Chloroquine, and Lidocaine solution; implantation or injectable dosage form,

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Phoenix Scientific, Inc. The NADA provides for veterinary prescription use of a solution containing embutramide, chloroquine phosphate, and lidocaine by intravenous injection for euthanasia
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

4. 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 Phoenix Scientific, Inc. The supplemental ANADA provides for veterinary prescription use of flunixin meglumine solution by intravenous injection in lactating dairy cattle for
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

5. Implantation or Injectable Dosage Form New Animal Drugs; Phenylbutazone Injection

RULES: Phenylbutazone,

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 the veterinary prescription use of phenylbutazone injectable solution in horses for relief of inflammatory conditions associated with
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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

RULES: Zeranol,

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two supplemental new animal drug applications (NADAs) filed by ScheringPlough Animal Health Corp. The supplemental NADAs provide for the addition of statements to labeling of subcutaneous implants containing zeranol warning against the use of
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

7. Implantation or Injectable Dosage Form New Animal Drugs; Trenbolone and Estradiol

RULES: Trenbolone acetate and estradiol implant,

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 Ivy Laboratories, Division of Ivy Animal Health, Inc. The supplemental ANADA provides for an additional dose of trenbolone acetate and estradiol implant for use in feedlot
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

8. Implantation or Injectable Dosage Form New Animal Drugs; Euthanasia Solution

RULES: Euthanasia solution,

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by MedPharmex, Inc. The ANADA provides for use of an injectable solution of pentobarbital sodium and phenytoin sodium for humane, painless, and rapid euthanasia of dogs.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
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