federal_register: E8-18093

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
E8-18093 Oral Dosage Form New Animal Drugs; Amprolium Rule 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 Phibro Animal Health. The supplemental NADA provides for label revisions associated with a previous change of sponsorship and other minor changes for amprolium concentrate solution to make medicated drinking water for chickens and turkeys for the treatment of coccidiosis. The product approval is being codified for the first time. 2008-08-06 2008 8 https://www.federalregister.gov/documents/2008/08/06/E8-18093/oral-dosage-form-new-animal-drugs-amprolium https://www.govinfo.gov/content/pkg/FR-2008-08-06/pdf/E8-18093.pdf Health and Human Services Department; Food and Drug Administration 221,199 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 Phibro Animal Health. The supplemental NADA provides for label revisions associated with a...

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