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# 3 NDAs Withdrawn Over Missed Annual Reports
- URL: https://www.fdaweb.com/3-ndas-withdrawn-over-missed-annual-reports/
- Published: 2021-09-13T12:00:00.000Z
- Updated: 2026-09-14T17:14:23.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150126

*Federal Register* notice: FDA is withdrawing approval of three NDAs because the application holders have repeatedly failed to file required annual reports. The withdrawn NDA are:

- NDA 016401: PolyMedica Industries’ Neopap (acetaminophen) suppositories
- NDA 050266: Storz Ophthalmics’ Achromycin (tetracycline hydrochloride ophthalmic ointment, 10 mg/gram
- NDA 050268: Storz Ophthalmics’ Achromycin (tetracycline HCl) ophthalmic suspension, 1%

To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-09-13/pdf/2021-19689.pdf?ref=fdaweb.com).