Primary regulatory
Rapamune (sirolimus) tablets: Medical Review.
FDA Center for Drug Evaluation and Research. Rapamune (sirolimus) tablets: Medical Review. NDA 21-110. 2000. Notes prior oral-solution approval on 1999-09-15.
U.S. Food and Drug AdministrationPublished 2000Accessed 2026-07-12
Registry record
Source metadata
- Publisher
- U.S. Food and Drug Administration
- Source type
- Primary regulatory
- Registry ID
research-rapa-01- Source code
- RAPA-01
Interpretation boundary
What this record can and cannot establish
Inclusion in the registry is not endorsement. The record supports only the claims that fit its design, population, date, and scope. Company, media, and community records can document that a claim was made without proving the claim itself.