federal_register: E8-5598
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| E8-5598 | Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline Solution | 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 Norbrook Laboratories, Ltd. The supplemental NADA provides for changing scientific nomenclature for a bovine pathogen on labeling for 300 milligrams per milliliter (mg/mL) strength oxytetracycline injectable solution. | 2008-03-20 | 2008 | 3 | https://www.federalregister.gov/documents/2008/03/20/E8-5598/implantation-or-injectable-dosage-form-new-animal-drugs-oxytetracycline-solution | https://www.govinfo.gov/content/pkg/FR-2008-03-20/pdf/E8-5598.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 Norbrook Laboratories, Ltd. The supplemental NADA provides for changing scientific... |