posaconazole Injectable Solution

Brand(s)
Noxafil
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Merck Sharp & Dohme Corp. (2015-07-28)
Oldest Current Product
2014-03-13
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\POSACONAZOLE
FDAOB
IV (INFUSION)\SOLUTION\POSACONAZOLE\rdfq
SPL Active
INTRAVENOUS\SOLUTION\POSACONAZOLE
SPL Moiety
INTRAVENOUS\SOLUTION\POSACONAZOLE

product(s) by strength(s)

posaconazole 18 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000854331NoxafilNDAMerck Sharp & Dohme Corp.2014-03-13POSACONAZOLEINTRAVENOUSSOLUTIONNDA205596b073b082-7b57-4423-8c06-4fd4263d6f84

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA205596NOXAFILMERCK SHARP AND DOHME CORP2014-03-13p5661151, PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS, SUBSTANCE
p9023790, PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS, SUBSTANCE
p5703079, PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS, SUBSTANCE
p8410077, SUBSTANCE
NDA205596_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA205596_001RXPOSACONAZOLE (300MG/16.7ML)SOLUTIONTrue2014-03-13NOXAFIL

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5661151 (view patent)2019-07-19NDA205596, NDA022003, NDA205053posaconazole Oral Suspension
posaconazole Delayed Release Oral Tablet
2p5703079 (view patent)2014-08-26NDA205596, NDA022003, NDA205053posaconazole Oral Suspension
posaconazole Delayed Release Oral Tablet
3p8410077 (view patent)2029-03-13NDA205596
4p9023790 (view patent)2031-07-04NDA205596

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1b073b082-7b57-4423-8c06-4fd4263d6f84 (view SPL)These highlights do not include all the information needed to use NOXAFIL safely and effectively. See full prescribing information for NOXAFIL. Noxafil (posaconazole) injection 18 mg/mLNoxafil (posaconazole) delayed-release tablets 100 mg Noxafil (posaconazole) oral suspension 40 mg/mLInitial U.S. Approval: 2006 (oral suspension)prescriptionHuman PrescriptionMerck Sharp & Dohme Corp.API MANUFACTURE, MANUFACTURE, PACK2015-07-2822000854331, 000851328, 000854324posaconazole Oral Suspension
posaconazole Delayed Release Oral Tablet

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