Regs.gov: Food and Drug Administration

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 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.