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# Guide on ANDA Waivers for pH Adjusters
- URL: https://www.fdaweb.com/guide-on-anda-waivers-for-ph-adjusters/
- Published: 2022-04-14T12:00:00.000Z
- Updated: 2026-09-14T17:40:48.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5151594

*Federal Register* notice: FDA is making available a draft guidance entitled *Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use*. The document is intended to assist ANDA applicants seeking approval of a drug that is qualitatively different or quantitatively different from a reference listed drug with respect to the pH adjuster. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-04-14/pdf/2022-08012.pdf?ref=fdaweb.com).