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# FDA Seeks to Withdraw 4 NDAs
- URL: https://www.fdaweb.com/fda-seeks-to-withdraw-4-ndas/
- Published: 2024-05-24T12:00:00.000Z
- Updated: 2026-09-14T14:31:49.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5157054

*Federal Register* notice: CDER is proposing to withdraw approval of four NDAs and is announcing an opportunity for the application holders to request a hearing on the proposal. The basis for the action is that the NDA holders have repeatedly failed to file required annual reports. The affected products are:

- Progynon Associates’ NDA #004652 Oreton (testosterone) pellets for subcutaneous implantation
- Sterling Winthrop’s NDA #013268 Winsteroid (stanozolol) tablets
- Duramed Research’s NDA #017455 Copper T Model TCu 200B (copper) intrauterine device
- Adhera Therapeutics’s NDA #205003 Prestalia (amlodipine besylate/perindopril arginine) tablets

To view the notice, click [here](https://public-inspection.federalregister.gov/2024-11609.pdf?ref=fdaweb.com).