Guidance: Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered To Be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting

TitleGuidance: Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered To Be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting
ToC Doc Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered To Be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting
Docket Number2024-13690
Type Notice
Subject Guidance:
Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered To Be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting
Publication Date2024-06-21
Last Updated Date 2024-06-20 08:17:26 -0400
Last Public Inspection2024-06-20
Filed At2024-06-20T08:45:00.000-04:00
PDF 2024-13690_PI.pdf (109140 bytes)
Download TXT / HTML / JSON
Number of Pages 5
Filing Typeregular
AgenciesFood and Drug Administration

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