dockets: FDA-2022-P-0558

Regulatory dockets from Regulations.gov — containers for related documents and comments in a rulemaking proceeding.

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id agency_id title docket_type last_modified object_id rin dkabstract category subtype keywords program short_title effective_date organization attrs_raw attr_source
FDA-2022-P-0558 FDA Requests that the FDA to determine if the Reference Listed Drug (RLD), OXANDRIN (oxandrolone tablets, USP) 2.5 mg and 10 mg, NDA 013718 owned by Gemini Laboratories LLC was voluntarily withdrawn from sale for reasons of safety or effectiveness to facilitate the approval of generic version. Nonrulemaking 2026-10-07T14:02:12Z 0b00006485000253                     list_pull

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