Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA) is withdrawing approval of three new animal drug applications (NADAs). This action is being taken 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 Part 522 [Docket No. FDA-2017-N-0002] AGENCY: Food and Drug Administration, HHS. ACTION: Notification of withdrawal. SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of three new animal drug applications (NADAs). This action is being taken at the sponsors' request because these products are no longer manufactured or marketed. DATES: Withdrawal of approval is effective April 9, 2018. 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: During July and August 2017, the following sponsors requested that FDA withdraw approval of the NADAs listed in the following table because the products are no longer manufactured or marketed: File No. Sponsor Product name 21 CFR section 047-055 Watson Laboratories, Inc., 311 Bonnie Circle, Corona, CA 92880 Chorionic Gonadotropin Powder for Injection 522.1081 ( printed page 13638) 104-606 Watson Laboratories, Inc., 311 Bonnie Circle, Corona, CA 92880 Dexamethasone Sodium Phosphate Injection 522.540 139-633 Wildlife Laboratories, Inc., 1230 W. Ash St., suite D, Windsor, CO 80550 WILDNIL (carfentanil citrate) Injection 522.300 Therefore, under authority delegated to the Commissioner of Food and Drugs, and in accordance with § 514.116 Notice of withdrawal of approval…
Other Federal Register documents from the same docket.
New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and Address
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and Address
Delcor Asset Corp. et al.; Withdrawal of Approval of 22 Abbreviated New Drug Applications
New Animal Drugs; Approval of New Animal Drug Applications
New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor's Address
Citation: 83 FR 13637
