dockets: FDA-2026-P-5578

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
FDA-2026-P-5578 FDA Requests that the FDA declare that an ANDA may be submitted for, Tranexamic Acid Tablets, USP 1300 mg a strength that differs from the currently approved RLD, LYSTEDA (Tranexamic Acid) tablets from AMRING PHARMACEUTICALS INC., which FDA approved in 650 mg strength prior to Nov, 13th 2009 under NDA #022430. Nonrulemaking 2026-05-14T19:18:14Z 0b000064b92d8ef2

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