Animal Drugs, Feeds, and Related Products; Tripelennamine Hydrochloride Injection
other · Food and Drug Administration · Rule · Published 1997-01-29 · Effective 1997-01-29 · 62 FR 4163
Document
Document number
97-2140
Federal Register citation
62 FR 4163
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1997-01-29
Effective date
1997-01-29
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to more clearly reflect the currently approved conditions of use of a new animal drug application (NADA) held by Solvay Animal Health, Inc. The NADA provides for use of tripelennamine hydrochloride injection for antihistaminic therapy in horses and cattle. The amendment provides for tolerances for drug residues in edible cattle tissues and in milk and the corresponding drug withdrawal and milk discard periods. When the NADA was reviewed under the National Academy of Sciences/National Research Council Drug Study Implementation Program and the results of the review finalized in 1983, this information was inadvertently omitted from the regulations.