Search Results: CFR:21 CFR Part 522

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

RULES: Trenbolone and estradiol,

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, Div. of Ivy Animal Health, Inc. The supplemental ANADA provides for the addition of tylosin tartrate to an approved subcutaneous implant containing
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

2. Implantation and Injectable Dosage Form New Animal Drugs; Ivermectin Injection

RULES: Ivermectin 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 Merial Ltd. The supplemental NADA provides for an increased period of protection from reinfection with three species of internal parasites of cattle following administration of ivermectin
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

3. Implantation or Injectable Dosage Form New Animal Drugs; Furosemide; Technical Amendment

RULES: Furosemide; technical amendment,

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the approved salts of injectable furosemide. This action is being taken to improve the accuracy of the regulations.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

4. Implantation or Injectable Dosage Form New Animal Drugs; Estradiol

RULES: Estradiol,

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 Ivy Laboratories, Division of Ivy Animal Health, Inc. The supplemental NADA provides for the addition of statements to labeling of subcutaneous implants containing estradiol warning
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

5. Implantation or Injectable Dosage Form New Animal Drugs; Penicillin G Procaine Aqueous Suspension; Technical

RULES: Penicillin G Procaine Aqueous implantation or injectable drug form; suspension; technical amendment,

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the approved preslaughter withdrawal period in cattle following use of a penicillin G procaine injectable suspension. This action is being taken to improve the accuracy of the regulations.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

6. Implantation or Injectable Dosage Form New Animal Drugs; Trenbolone Acetate and Estradiol Benzoate

RULES: Trenbolone acetate and estradiol benzoate,

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, Division of Wyeth. The supplemental NADA provides for the addition of statements to labeling of subcutaneous implants containing trenbolone acetate and estradiol
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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

RULES: Insulin; implantation or injectable dosage,

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Intervet, Inc. The NADA provides for the veterinary prescription use of an injectable suspension of zinc insulin of porcine origin for the reduction of hyperglycemia and hyperglycemiaassociated
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

8. Implantation or Injectable Dosage Form New Animal Drugs; Estradiol Benzoate and Testosterone Propionate

RULES: Estradiol benzoate and testosterone propinate,

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of supplemental new animal drug applications (NADAs) filed by Fort Dodge Animal Health, Division of Wyeth, and Ivy Laboratories, Division of Ivy Animal Health, Inc. The supplemental NADAs provide for the addition of statements to labeling of
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

9. Implantation or Injectable Dosage Form New Animal Drugs; Ivermectin and Clorsulon Injection

RULES: Ivermectin and clorsulon 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 Merial Ltd. The supplemental NADA provides for an increased period of protection from reinfection with three species of internal parasites following administration of an ivermectin and
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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

RULES: Trenbolone acetate and estradiol,

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 Intervet Inc.; three supplemental abbreviated new animal drug applications (ANADAs) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc.; and a supplemental ANADA filed by
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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

RULES: Oxytetracyline,

The Food and Drug Administration (FDA) is amending the animal drug regulations for oxytetracycline injectable solutions. The regulations for oxytetracycline injectable solutions are also being revised to conform to a current format. These changes are being made to improve the organization and readability of the regulations.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

12. Implantation or Injectable Dosage Form New Animal Drugs; Progesterone and Estradiol Benzoate

RULES: Progesterone and estradiol benzoate,

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of supplemental new animal drug applications (NADAs) filed by Fort Dodge Animal Health, Division of Wyeth, and Ivy Laboratories, Division of Ivy Animal Health, Inc. The supplemental NADAs provide for the addition of statements to labeling of
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

13. Implantation or Injectable Dosage Form New Animal Drugs; Acepromazine Maleate Injection

RULES: Acepromazine maleate injectable solution,

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 Boehringer Ingelheim Vetmedica, Inc. The ANADA provides for the veterinary prescription use of acepromazine maleate injectable solution in dogs, cats, and horses as a tranquilizer.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

14. Implantation or Injectable Dosage Form New Animal Drugs; Trenbolone Acetate

RULES: Trenbalone acetate,

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) and an abbreviated supplemental new animal drug application (ANADA) filed by Intervet, Inc., and Ivy Laboratories, Division of Ivy Animal Health, Inc., respectively. The supplemental NADA and ANADA
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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

RULES: Trenbolone and estradiol,

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 Fort Dodge Animal Health, Division of Wyeth. The ANADA provides for use of three different strength trenbolone acetate and estradiol implants in cattle.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

16. Implantation or Injectable Dosage Form New Animal Drugs; N- Butylscopolammonium Bromide

RULES: N-butylscopolammonium bromide; implantation or injectable form,

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Boehringer Ingelheim Vetmedica, Inc. The NADA provides for the veterinary prescription use of a solution of N
butylscopolammonium bromide by intravenous injection for the control of abdominal pain
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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

RULES: Trenbolone and estradiol,

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 the addition of tylosin tartrate to an approved subcutaneous implant containing
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

18. Implantation or Injectable Dosage Form New Animal Drugs; Ceftiofur

RULES: Ceftiofur,

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 Pharmacia & Upjohn Co. The supplemental NADAs provide for establishing a 4day preslaughter withdrawal period in swine injected with either a solution made from ceftiofur sodium powder
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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

RULES: Lincomycin injectable solution,

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 Phoenix Scientific, Inc. 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

20. Implantation or Injectable Dosage Form New Animal Drugs; Romifidine

RULES: Romifidine hydrochloride injectable solution,

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Boehringer Ingelheim Vetmedica, Inc. The NADA provides for the veterinary prescription use of romifidine hydrochloride injectable solution in horses as a sedative and analgesic, and as a preanesthetic
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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

RULES: Trenbolone and estradiol,

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 the addition of tylosin tartrate to an approved subcutaneous implant containing
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

22. 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 Agri Laboratories, Ltd. The supplemental ANADA provides for use of flunixin meglumine solution by intravenous injection for control of fever and inflammation in beef cattle
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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