FDA Approval Activities for this Drug…

Rapamune (sirolimus) Solution & Tablets, 1 mg/mL & 1 and 2 mg respectively, Wyeth NDA 21-083/S-006 & 21-110/S-004 4/11/03 4/18/03 4/11/03 Rapamune (sirolimus) Solution & Tablets, Wyeth NDA 21-083/S-015 & 21-110/S-015 10/2/03 10/10/03 10/10/03 Rapamune (sirolimus) Solution & Tablets, 1 mg/mL & 1 and 2 mg respectively, Wyeth NDA 21-083/S-014 & 21-110/S-013 3/19/03 4/1/03 3/26/03 Rapamune (sirolimus) Solution & Tablets, 1 mg/mL & 1 mg respectively, Wyeth NDA 21-083/S-012 & 21-110/S-011 1/31/03 2/12/03 2/13/03 Rapamune (sirolimus) Solution & Tablets, 1 mg/mL & 1 mg respectively, Wyeth NDA 21-083/S-005; S-007; S-008; S-009; S-010 & 21-110/S-001; S-005; S-007; S-009; S-010 1/23/03 1/27/03 1/23/03 Rapamune (sirolimus) Tablets, Wyeth NDA 21-110/S3 8/22/02 8/26/02 Rapamune (sirolimus) Tablets, 1 mg/ml, Wyeth-Ayerst NDA 21-110 8/25/00 9/6/00 10/11/01 Rapamune (sirolimus) Solution, 1 mg/ml, Wyeth-Ayerst NDA 21-083 9/15/99 1/21/00 Rapamune Indication: Prophylaxis of organ rejection in patients receiving renal transplants. Rapamune (sirolimus) Tablets, Wyeth Pharmaceuticals Rapamune (sirolimus) Oral Solution, Wyeth Pharmaceuticals, Labeling Revision | Rapamune (sirolimus) Tablets, Wyeth Pharmaceuticals, Labeling Revision | Rapamune (sirolimus) Oral Solution, Wyeth Pharma, Patient Population Altered | Rapamune (sirolimus) Tablets, Wyeth Pharma, Patient Population Altered

For the latest approval information, please see the main page.