Toremifene Oral Tablet

Brand(s)
Fareston
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Gtx, Inc. (2011-03-24)
Oldest Current Product
1997-06-30
License(s)
NDA
RxNORM
ORAL TABLET\TOREMIFENE
FDAOB
ORAL\TABLET\TOREMIFENE CITRATE
SPL Active
ORAL\TABLET\TOREMIFENE CITRATE
SPL Moiety
ORAL\TABLET\TOREMIFENE

product(s) by strength(s)

toremifene 60 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1113990005FarestonNDAGtx, Inc.1997-06-30TOREMIFENE CITRATEORALTABLETNDA020497a6ff9761-7442-4bff-9e50-858c03e27fd0

application(s)

#idtitleapplicantapprovedapproved drug
1NDA020497FARESTONPROSTRAKAN INC1997-05-29NDA020497_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA020497_001RXTOREMIFENE CITRATE (EQ 60MG BASE)ORALTABLETTrue1997-05-29FARESTON

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
12cab8dd1-3a10-48e6-86ce-0e5275ed49e5 (view SPL)These highlights do not include all the information needed to use FARESTON safely and effectively. See full prescribing information for FARESTON. FARESTON (toremifene citrate) 60 mg Tablets oral administration Initial U.S. Approval: [1997]prescriptionHuman PrescriptionProstrakan, Inc.manufacture2012-10-151427470327
2a6ff9761-7442-4bff-9e50-858c03e27fd0 (view SPL)These highlights do not include all the information needed to use FARESTON safely and effectively. See full prescribing information for FARESTON.FARESTON (toremifene citrate) 60 mg Tablets oral administrationInitial U.S. Approval: [1997]prescriptionHuman PrescriptionGtx, Inc.ANALYSIS, MANUFACTURE, RECOVERY, RELABEL, REPACK2011-03-247113990005

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