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RULES: Tulathromycin,
Published: 2008-10-08
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
RULES: Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline Solution,
Published: 2008-03-20
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
RULES: Implantation or Injectable Dosage Form New Animal Drugs; Penicillin G Procaine Aqueous Suspension,
Published: 2008-03-17
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 IVX Animal Health, Inc. The supplemental
NADA provides for changing scientific nomenclature for a swine pathogen
on labeling for penicillin G procaine aqueous suspension.
RULES: Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor; Ferric Oxide Injection etc.,
Published: 2008-03-10
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
RULES: Tulathromycin,
Published: 2008-02-01
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
RULES: Implantation or Injectable Dosage Form New Animal Drugs; Flunixin,
Published: 2008-01-16
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
RULES: Implantation or Injectable Dosage Form New Animal Drugs; Flunixin,
Published: 2008-05-15
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
RULES: Cefovecin,
Published: 2008-05-22
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.
RULES: Florfenicol,
Published: 2008-04-18
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.
RULES: Implantation or Injectable Dosage Form New Animal Drugs; Butorphanol,
Published: 2008-06-02
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 Lloyd, Inc. The ANADA provides for the
veterinary prescription use of butorphanol tartrate injectable solution
in horses for the relief of pain.
RULES: Insulin,
Published: 2008-04-18
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
RULES: Ceftiofur Hydrochloride,
Published: 2008-08-06
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
RULES: Implantation or Injectable Dosage Form New Animal Drugs; Enrofloxacin,
Published: 2008-04-02
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.
RULES: Ceftiofur Crystalline Free Acid,
Published: 2008-10-08
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
RULES: Implantation or Injectable Dosage Form New Animal Drugs; Penicillin G Benzathine and Penicillin G Procaine Suspension,
Published: 2008-03-31
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 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