federal_register: 2010-21296
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2010-21296 | New Animal Drugs; Change of Sponsor; Withdrawal of Approval of New Animal Drug Applications; Deslorelin Acetate; Dichlorophene and Toluene Capsules; Pyrantel Pamoate Suspension | Rule | The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) from Peptech Animal Health Pty, Ltd. to Dechra, Ltd. and for an abbreviated new animal drug application (ANADA) from Church & Dwight Co., Inc., to Pegasus Laboratories, Inc. In addition, FDA is removing those portions of the regulations that reflect approval of two other NADAs transferred from Church & Dwight Co., Inc., to Pegasus Laboratories, Inc., for which voluntary withdrawal of approval was requested after the change of sponsorship. In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these two NADAs. | 2010-08-27 | 2010 | 8 | https://www.federalregister.gov/documents/2010/08/27/2010-21296/new-animal-drugs-change-of-sponsor-withdrawal-of-approval-of-new-animal-drug-applications-deslorelin | https://www.govinfo.gov/content/pkg/FR-2010-08-27/pdf/2010-21296.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 a change of sponsor for a new animal drug application (NADA) from Peptech Animal Health Pty, Ltd. to Dechra, Ltd. and for an abbreviated new animal drug... |