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# Intellipharmaceutics Refiles NDA for Oxycodone ER
- URL: https://www.fdaweb.com/intellipharmaceutics-refiles-nda-for-oxycodone-er/
- Published: 2019-03-04T12:00:00.000Z
- Updated: 2026-09-15T01:09:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143514

Intellipharmaceutics International has resubmitted an NDA for its oxycodone ER product candidate, indicated for treating pain. In 2018, FDA issued Intellipharmaceutics a complete response letter on the NDA that provided certain recommendations and requests for information, including that it complete the relevant Category 2 and Category 3 studies to assess the product’s abuse-deterrent properties by oral and nasal routes of administration, according to the company. It also requested additional information related to the inclusion of a blue dye in the drug’s formulation.