Sirolimus Oral Solution
- Brand(s)
- Rapamune
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc. (2015-10-14)
- Oldest Current Product
- 1999-09-01
- License(s)
- NDA
- RxNORM
- ORAL SOLUTION\SIROLIMUS
- FDAOB
- ORAL\SOLUTION\SIROLIMUS
- SPL Active
- ORAL\SOLUTION\SIROLIMUS
- SPL Moiety
- ORAL\SOLUTION\SIROLIMUS
product(s) by strength(s)
sirolimus 1 mg/ml oral solution
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000081030 | Rapamune | NDA | Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc. | 1999-09-01 | SIROLIMUS | ORAL | SOLUTION | NDA021083 | 3275b824-3f82-4151-2ab2-0036a9ba0acc |
application(s)
| # | id | title | applicant | approved | exclusivity | approved drug |
|---|---|---|---|---|---|---|
| 1 | NDA021083 | RAPAMUNE | PF PRISM CV | 1999-09-15 | ORPHAN DRUG EXCLUSIVITY [2022-05-28] | NDA021083_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA021083_001 | RX | SIROLIMUS (1MG/ML) | ORAL | SOLUTION | True | 1999-09-15 | RAPAMUNE |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) | in other drug docs |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 3275b824-3f82-4151-2ab2-0036a9ba0acc (view SPL) | These highlights do not include all the information needed to use Rapamune safely and effectively.See full prescribing information for Rapamune. RAPAMUNE (sirolimus) ORAL SOLUTION AND TABLETSInitial U.S. Approval: 1999 | prescription | Human Prescription | Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc. | ANALYSIS, MANUFACTURE | 2015-10-14 | 47 | 000081030, 000081040, 000081041, 000081042 | Sirolimus Oral Tablet |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII