Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of June 21, 2017 (82 FR 28322). The document announced the withdrawal of approval of 121 new drug applications (NDAs) and 161 abbreviated new drug applications from multiple applicants, withdrawn as of July 21, 2017. The document indicated that FDA was withdrawing approval of NDA 204508, Clinolipid 20% (olive oil and soybean oil) USP, 16%/4%, after receiving a request from the NDA holder, Baxter Healthcare Corp. (Baxter), 32650 N Wilson Rd., Round Lake, IL 60073. Before the approval of NDA 204508 was withdrawn, Baxter informed FDA that it did not want the approval of this NDA withdrawn. Because Baxter timely requested that approval of this NDA not be withdrawn, the approval of NDA 204508 is still in effect.
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-3203] AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY: The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of June 21, 2017 ( 82 FR 28322 ). The document announced the withdrawal of approval of 121 new drug applications (NDAs) and 161 abbreviated new drug applications from multiple applicants, withdrawn as of July 21, 2017. The document indicated that FDA was withdrawing approval of NDA 204508, Clinolipid 20% (olive oil and soybean oil) USP, 16%/4%, after receiving a request from the NDA holder, Baxter Healthcare Corp. (Baxter), 32650 N Wilson Rd., Round Lake, IL 60073. Before the approval of NDA 204508 was withdrawn, Baxter informed FDA that it did not want the approval of this NDA withdrawn. Because Baxter timely requested that approval of this NDA not be withdrawn, the approval of NDA 204508 is still in effect. FOR FURTHER INFORMATION CONTACT: Florine Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6366, Silver Spring, MD 20993-0002, 301-796-3601. SUPPLEMENTARY INFORMATION: In the Federal Register of Wednesday, June 21, 2017, appearing on page 28322 in FR Doc. 2017-12908 , the following correction is made: On page 28329, in table 1, the entry for NDA 204508 is removed. Dated: February 21, 2018. Leslie Kux, Associate Commissioner for Po…
Other Federal Register documents from the same docket.
Citation: 83 FR 8485
