Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) and two abbreviated new animal drug applications (ANADAs) at the sponsors' request because the products are no longer manufactured or marketed.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration 21 CFR Parts 520, 522, and 529 [Docket No. FDA-2019-N-0002] AGENCY: Food and Drug Administration, HHS. ACTION: Notification of withdrawal. ( printed page 4211) SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) and two abbreviated new animal drug applications (ANADAs) at the sponsors' request because the products are no longer manufactured or marketed. DATES: Withdrawal of approval is applicable February 3, 2020. FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5761, sujaya.dessai@fda.hhs.gov . SUPPLEMENTARY INFORMATION: Fleming Laboratories, Inc., P.O. Box 34384, Charlotte, NC 28234, has requested that FDA withdraw approval of NADA 010-005 for use of WAZINE (dipiperazine sulfate and piperazine hydrochloride) Soluble Powders because the product is no longer manufactured or marketed. Also, Halocarbon Products Corp., 6525 The Corners Pkwy., Suite 200, Peachtree Corners, GA 30092, has requested that FDA withdraw approval of ANADA 200-200 for use of Halothane USP (halothane) because the product is no longer manufactured or marketed. Lastly, Mylan Institutional LLC, 4901 Hiawatha Dr., Rockford, IL 61103, has requested that FDA withdraw approval of ANADA 200-472 for use of Fomepizole Injection because the product is no longer manufacture…
Other Federal Register documents from the same docket.
New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsors' Name and Addresses
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsor; Change of Sponsor's Address
New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor's Name and Address
New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
Citation: 85 FR 4210
