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# FDA Withdraws Xanodyne NDA
- URL: https://www.fdaweb.com/fda-withdraws-xanodyne-nda/
- Published: 2016-04-15T12:00:00.000Z
- Updated: 2026-09-14T20:55:04.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135391

*Federal Register* Notice: FDA is correcting a 3/10/14 *Federal Register* notice that withdrew approval of 8 NDAs and 46 ANDAs for prescription pain medications containing propoxyphene from multiple applicants. The document failed to withdraw approval of an Xanodyne Pharmaceuticals NDA 017507 for Darvocet-N 100 (propoxyphene napsylate and acetaminophen) Suspension, 100 mg/650 mg/mL. The company wrote to FDA asking it to withdraw approval of NDA 017507 and waiving its opportunity for a hearing. The agency confirms the withdrawal of approval. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-04-15/pdf/2016-08689.pdf?ref=fdaweb.com)