Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA) is withdrawing approval of two new animal drug applications (NADAs) at the sponsors' request because these 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 524 and 558 [Docket No. FDA-2019-N-0002] AGENCY: Food and Drug Administration, HHS. ACTION: Notification of withdrawal. SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of two new animal drug applications (NADAs) at the sponsors' request because these products are no longer manufactured or marketed. DATES: Withdrawal of approval is effective August 19, 2019. 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: Boehringer Ingelheim Animal Health USA Inc., 3239 Satellite Blvd., Duluth, GA 30096, has requested that FDA withdraw approval of NADA 141-054 for use of LINCOMIX (lincomycin hydrochloride) and IVOMEC (ivermectin) Type A medicated articles in the manufacture of 2-way, combination drug Type C medicated swine feeds because the product is no longer manufactured or marketed. Also, Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140, has requested that FDA withdraw approval of NADA 141-337 for use of RECOVYRA (fentanyl) Transdermal Solution for Dogs because the product is no longer manufactured or marketed. Therefore, under authority delegated to the Commissioner of Food and Drugs and in accordance with § 514.116 Notice of withdrawal of approval of application ( 21 CFR 514.116 ), no…
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; Withdrawal of Approval of a New Animal Drug Application; Withdrawal of Approval of Abbreviated New Animal Drug Applications
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
Citation: 84 FR 39187
