Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 22 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
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 [Docket No. FDA-2017-N-0002] AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA or Agency) is withdrawing approval of 22 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: Approval is withdrawn as of February 16, 2018. FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945, Trang.Tran@fda.hhs.gov . SUPPLEMENTARY INFORMATION: The holders of the applications listed in table 1 have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process in § 314.150(c) ( 21 CFR 314.150(c) ). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling. Table 1—ANDAs for Which FDA Is Withdrawing Approval Application No. Drug Applicant ANDA 060577 Mycostatin (nystatin) Vaginal Tablets, 100,000 units Delcor Asset Corp., 411 South State St., Suite E-100, Newtown, PA 18940. AND…
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
New Animal Drugs; Withdrawal of Approval of New Animal 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 2455
