# Oral Dosage Form New Animal Drugs; Tiamulin
> **Food and Drug Administration** · Final rule. · Published 2009-02-13 · Effective 2009-02-13 · 74 FR 7180
## Document
- **Document number:** E9-3131
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 74 FR 7180
- **CFR reference:** 21 CFR 520
- **Publication date:** 2009-02-13
- **Effective date:** 2009-02-13
- **HHS docket:** Docket No. FDA-2009-N-0665
## 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 Novartis Animal Health US, Inc. The supplemental NADA provides for removal of a 250-pound weight restriction and the addition of a reproductive caution statement to labeling of tiamulin concentrate solution used in drinking water for the treatment of certain bacterial respiratory and enteric diseases in swine.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2009/02/13/E9-3131/oral-dosage-form-new-animal-drugs-tiamulin)
---
*AI Analytics · CC0 1.0*