Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 | Rapamune (sirolimus) Oral Solution, Wyeth Pharma, Labeling Revision | Rapamune (sirolimus) Tablets, Wyeth Pharma, Labeling Revision | Rapamune (sirolimus) Oral Solution, Wyeth Pharma, Labeling Revision | Rapamune (sirolimus) Tablets, Wyeth Pharma, Labeling Revision | Rapamune (sirolimus) Oral Solution, Wyeth Pharma, Efficacy Supp. w/Clinical Data & Labeling Revision | Rapamune (sirolimus) Tablets, Wyeth Pharma, Efficacy Supp. w/Clinical Data & Labeling Revision | Rapamune (sirolimus) Oral Solution, Wyeth Pharma, Labeling Revision | Rapamune (sirolimus) Tabelts, Wyeth Pharma, Labeling Revision | Rapamune (sirolimus) Oral Solution, Wyeth Pharma, Labeling Revision | Rapamune (sirolimus) Tablets, Wyeth Pharma, Labeling Revision | Rapamune (sirolimus) Oral Solution, Wyeth Pharma, Patient Population Altered | Rapamune (sirolimus) Tablets, Wyeth Pharma, Patient Population Altered | Rapamune (sirolimus) Oral Solution, Wyeth Pharma, Labeling Revision | Rapamune (sirolimus) Tablets, Wyeth Pharma, Labeling Revision | Rapamune (sirolimus) Oral Solution, Wyeth Pharma, Labeling Revision | Rapamune (sirolimus) Tablets, Wyeth Pharma, Labeling Revision | Rapamune (Sirolimus) Oral Solution, Wyeth Pharma, New or Modified Indication | Rapamune (Sirolimus) Tablets, Wyeth Pharma, New or Modified Indication | Rapamune (sirolimus) Oral Solution, Wyeth Pharma, Labeling Revision | Rapamune (sirolimus) Tablets, Wyeth Pharma, Labeling Revision ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com