temozolomide Injectable Solution

Brand(s)
Temodar
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Merck Sharp & Dohme Corp. (2015-05-12)
Oldest Current Product
2009-02-27
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\TEMOZOLOMIDE
FDAOB
INTRAVENOUS\POWDER\TEMOZOLOMIDE
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\TEMOZOLOMIDE
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\TEMOZOLOMIDE

product(s) by strength(s)

temozolomide 2.5 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000851381TemodarNDAMerck Sharp & Dohme Corp.2009-02-27TEMOZOLOMIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA022277046a9011-3911-4d3f-a15f-fbb56d5aad56

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA022277TEMODARMERCK SHARP AND DOHME CORP2009-02-27p6987108, SUBSTANCE
p7786118, SUBSTANCE
p8623868, SUBSTANCE
NDA022277_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022277_001RXTEMOZOLOMIDE (100MG/VIAL)INTRAVENOUSPOWDERTrue2009-02-27TEMODAR

patent(s)

#idexpiration dateapplication(s)
1p6987108 (view patent)2023-09-08NDA022277
2p7786118 (view patent)2023-02-21NDA022277
3p8623868 (view patent)2023-02-21NDA022277

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1046a9011-3911-4d3f-a15f-fbb56d5aad56 (view SPL)These highlights do not include all the information needed to use TEMODAR safely and effectively. See full prescribing information for TEMODAR. TEMODAR (temozolomide) CapsulesTEMODAR (temozolomide) for Injection administered via intravenous infusionInitial U.S. Approval: 1999prescriptionHuman PrescriptionMerck Sharp & Dohme Corp.API MANUFACTURE, MANUFACTURE, PACK2015-05-1222000851381, 000851366, 000851417, 000851425, 000851430, 000851519, 000853004temozolomide Oral Capsule

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