Search Results: CFR:21 CFR Part 522

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1. 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 veterinarian prescription use of tulathromycin injectable solution for the treatment of bovine foot rot (interdigital necrobacillosis) in
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

2. Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline Solution

RULES: Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline 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 Norbrook Laboratories, Ltd. The supplemental NADA provides for changing scientific nomenclature for a bovine pathogen on labeling for 300 milligrams per milliliter (mg/mL) strength
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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

RULES: Implantation or Injectable Dosage Form New Animal Drugs; Penicillin G Procaine Aqueous 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 IVX Animal Health, Inc. The supplemental NADA provides for changing scientific nomenclature for a swine pathogen on labeling for penicillin G procaine aqueous suspension.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

4. Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor; Ferric Oxide Injection; Gleptoferron

RULES: Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor; Ferric Oxide Injection etc.,

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for two new animal drug applications (NADAs) for injectable iron supplements used in baby pigs from Boehringer Ingelheim Vetmedica, Inc., to Animal Health Pharmaceuticals, LLC. In addition, FDA is taking this opportunity to consolidate
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

5. 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 veterinarian prescription use of tulathromycin injectable solution for the treatment of infectious bovine keratoconjunctivitis and the
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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

RULES: Implantation or Injectable Dosage Form New Animal Drugs; 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

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

RULES: Implantation or Injectable Dosage Form New Animal Drugs; 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 IVX Animal Health, Inc. The [[Page 28037]]
supplemental ANADA provides for the veterinary prescription use of flunixin meglumine solution by intravenous injection in lactating
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

8. Implantation or Injectable Dosage Form New Animal Drugs; Cefovecin

RULES: Cefovecin,

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Pfizer, Inc. The NADA provides for the veterinary prescription use of a solution of cefovecin sodium in cats and dogs by subcutaneous injection for the treatment of skin infections.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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

RULES: Florfenicol,

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by ScheringPlough Animal Health Corp. The NADA provides for use of florfenicol injectable solution for the treatment of bovine respiratory disease.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

10. Implantation or Injectable Dosage Form New Animal Drugs; Butorphanol

RULES: Implantation or Injectable Dosage Form New Animal Drugs; Butorphanol,

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 Lloyd, Inc. The ANADA provides for the veterinary prescription use of butorphanol tartrate injectable solution in horses for the relief of pain.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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

RULES: Insulin,

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 veterinary prescription use of an injectable suspension of porcine insulin zinc for the reduction of hyperglycemia and
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

12. Implantation or Injectable Dosage Form New Animal Drugs; Ceftiofur Hydrochloride

RULES: Ceftiofur Hydrochloride,

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Pharmacia and Upjohn Co., a Division of Pfizer, Inc. The NADA provides for the veterinary prescription use of a ceftiofur hydrochloride injectable suspension for treatment of various bacterial
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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

RULES: Implantation or Injectable Dosage Form New Animal Drugs; Enrofloxacin,

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 the use of enrofloxacin injectable solution in female dairy cattle less than 20 months of age.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

14. Implantation or Injectable Dosage Form New Animal Drugs; Ceftiofur Crystalline Free Acid

RULES: Ceftiofur Crystalline Free Acid,

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 veterinarian prescription use of ceftiofur crystalline free acid injectable suspension for the
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

15. Implantation or Injectable Dosage Form New Animal Drugs; Penicillin G Benzathine and Penicillin G Procaine Suspension

RULES: Implantation or Injectable Dosage Form New Animal Drugs; Penicillin G Benzathine and Penicillin G Procaine 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 IVX Animal Health, Inc. The supplemental NADA provides for changing scientific nomenclature for a bovine pathogen on labeling for penicillin G benzathine and penicillin G procaine injectable
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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