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FDA Approves Labeling for RS, ANDA 202682

The U.S. Food and Drug Administration (FDA) has approved labeling for RS, as indicated by ANDA 202682. This approval was posted on March 13, 2026, and pertains to specific drug product labeling.

FDA Acknowledgment Letter to Athyna Pharma

The FDA's Center for Drug Evaluation and Research (CDER) has issued an acknowledgment letter to Athyna Pharma, LLC. This notice confirms receipt of a submission from the company.

FDA Approves Labeling for RLD, NDA N021411

The FDA has approved labeling for RLD (Reference Listed Drug) and NDA (New Drug Application) N021411. This notice indicates a regulatory action related to drug approval and labeling requirements.

FDA Natural Family Planning Curricula Background Material

The FDA has posted background material related to Natural Family Planning curricula. This notice provides informational resources for interested parties.

FDA Document - Copyrighted Content

The FDA has posted a document containing copyrighted content, identified by the docket number FDA-2026-P-2640-0004. The content itself is restricted due to copyright. This notice serves to inform the public of the document's availability and its restricted nature.

FDA Proposes Pediatric Labeling Changes for ADHD Drugs

The FDA has issued a proposal to update the pediatric labeling for certain Attention Deficit Hyperactivity Disorder (ADHD) drugs. This consultation seeks public comment on the proposed changes to ensure accurate and up-to-date information for healthcare providers and patients regarding the use of these medications in children.

Osteopathic Family Physician Background Material

The FDA has posted background material related to Osteopathic Family Physicians. This notice provides informational content for stakeholders in the healthcare field.

FDA Acknowledgment Letter to North Bay Productions

The FDA's Division of Management and Budget (DMB) issued an acknowledgment letter to North Bay Productions on March 13, 2026. This notice confirms receipt of a submission from the company.

FDA Variance Approval Letter

The FDA has issued a variance approval letter to Richard Lathrop, authored by CDRH. The letter, which contains restricted personally identifiable information, has been redacted and is available for download.

FDA Natural Family Planning Review

The FDA has posted a review concerning Natural Family Planning methods. This document provides updated information and guidance related to these methods.