posaconazole Delayed Release Oral Tablet

Brand(s)
Noxafil
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Merck Sharp & Dohme Corp. (2015-07-28)
Oldest Current Product
2013-11-25
License(s)
NDA
RxNORM
DELAYED RELEASE ORAL TABLET\POSACONAZOLE
FDAOB
ORAL\TABLET, DELAYED RELEASE\POSACONAZOLE
SPL Active
ORAL\TABLET, COATED\POSACONAZOLE
SPL Moiety
ORAL\TABLET, COATED\POSACONAZOLE

product(s) by strength(s)

posaconazole 100 mg delayed release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000854324NoxafilNDAMerck Sharp & Dohme Corp.2013-11-25POSACONAZOLEORALTABLET, COATEDNDA205053b073b082-7b57-4423-8c06-4fd4263d6f84

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA205053NOXAFILMERCK SHARP AND DOHME CORP2013-11-25p5661151, PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS, SUBSTANCE
p5703079, PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS, SUBSTANCE
NDA205053_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA205053_001RXPOSACONAZOLE (100MG)ORALTABLET, DELAYED RELEASETrue2013-11-25NOXAFIL

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5661151 (view patent)2019-07-19NDA205053, NDA022003, NDA205596posaconazole Oral Suspension
posaconazole Injectable Solution
2p5703079 (view patent)2014-08-26NDA205053, NDA022003, NDA205596posaconazole Oral Suspension
posaconazole Injectable Solution

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, PACK2015-07-2822000854324, 000851328, 000854331posaconazole Oral Suspension
posaconazole Injectable Solution

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