> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Tracking of NDA/ANDA Review Info
- URL: https://www.fdaweb.com/fda-tracking-of-nda-anda-review-info/
- Published: 2021-01-14T12:00:00.000Z
- Updated: 2026-09-14T16:42:48.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5148451

*Federal Register* notice: HHS is requiring FDA to publish annually on its Web site the following NDA/ANDA review information: (**a**) the date on which FDA filed an NDA or received an ANDA; (**b**) the date on which FDA approved the NDA or ANDA; (**c**) the total days elapsed between the dates in (a) and (b); and (**d**) the total days in excess of 180-days the date of (c). For example, if an NDA was “filed” on January 25, 2021 and approved on 12/27/2021, then the total days elapsed for review would be 336 days, and the days in excess of 180 days would be 156 days. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-00786.pdf?ref=fdaweb.com).