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)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000081030RapamuneNDAWyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.1999-09-01SIROLIMUSORALSOLUTIONNDA0210833275b824-3f82-4151-2ab2-0036a9ba0acc

application(s)

#idtitleapplicantapprovedexclusivityapproved drug
1NDA021083RAPAMUNEPF PRISM CV1999-09-15ORPHAN DRUG EXCLUSIVITY [2022-05-28]NDA021083_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021083_001RXSIROLIMUS (1MG/ML)ORALSOLUTIONTrue1999-09-15RAPAMUNE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
13275b824-3f82-4151-2ab2-0036a9ba0acc (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: 1999prescriptionHuman PrescriptionWyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.ANALYSIS, MANUFACTURE2015-10-1447000081030, 000081040, 000081041, 000081042Sirolimus Oral Tablet

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII