Oral Dosage Form New Animal Drugs; Sulfadimethoxine/Ormetoprim Tablets
other · US Department of Health and Human Services · Rule · Published 1996-09-05 · Effective 1996-09-05 · 61 FR 46719
Document
Document number
96-22694
Federal Register citation
61 FR 46719
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
US Department of Health and Human Services
Publication date
1996-09-05
Effective date
1996-09-05
Abstract
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 approved NADA provides for oral use of sulfadimethoxine/ormetoprim tablets in dogs for the treatment of certain bacterial skin and soft tissue infections (wounds and abscesses). The supplement adds the treatment of certain bacterial urinary tract infections. This product is limited to veterinary prescription use.