Implantation or Injectable Dosage Form New Animal Drugs; Ceftiofur Hydrochloride Sterile Suspension
other · Food and Drug Administration · Rule · Published 1998-10-06 · Effective 1998-10-06 · 63 FR 53578
Document
Document number
98-26650
Federal Register citation
63 FR 53578
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1998-10-06
Effective date
1998-10-06
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two supplemental new animal drug applications (NADA's) filed by Pharmacia & Upjohn Co. One supplemental NADA provides for veterinary prescription use of ceftiofur hydrochloride sterile suspension for intramuscular or subcutaneous injection in cattle for treatment of bovine respiratory disease and acute bovine interdigital necrobacillosis. The second supplemental NADA provides for a revised label warning against use in veal calves.