miltefosine Oral Capsule

Brand(s)
Impavido
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Paladin Therapeutics Inc. (2014-03-28)
Oldest Current Product
2014-09-19
License(s)
NDA
RxNORM
ORAL CAPSULE\MILTEFOSINE
FDAOB
ORAL\CAPSULE\MILTEFOSINE
SPL Active
ORAL\CAPSULE\MILTEFOSINE
SPL Moiety
ORAL\CAPSULE\MILTEFOSINE

product(s) by strength(s)

miltefosine 50 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1617440050ImpavidoNDAPaladin Therapeutics Inc.2014-09-19MILTEFOSINEORALCAPSULENDA204684d6658aeb-7bc1-4eef-ad0d-0a873ddbecf5

application(s)

#idtitleapplicantapprovedexclusivityapproved drug
1NDA204684IMPAVIDOKNIGHT THERAPEUTICS USA INC2014-03-19ORPHAN DRUG EXCLUSIVITY [2021-03-19]
NEW CHEMICAL ENTITY [2019-03-19]
NDA204684_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA204684_001RXMILTEFOSINE (50MG)ORALCAPSULETrue2014-03-19IMPAVIDO

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1bcb387ac-2e90-4f5e-94b2-d3635190678e (view SPL)These highlights do not include all the information needed to use IMPAVIDO safely and effectively. See full prescribing information for IMPAVIDO. IMPAVIDO (miltefosine) capsules, for oral useInitial U.S. Approval: 2014prescriptionHuman PrescriptionProfounda, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2015-10-121690510300
2d6658aeb-7bc1-4eef-ad0d-0a873ddbecf5 (view SPL)These highlights do not include all the information needed to use IMPAVIDO safely and effectively. See full prescribing information for IMPAVIDO. IMPAVIDO (miltefosine) capsules, for oral useInitial U.S. Approval: 2014prescriptionHuman PrescriptionPaladin Therapeutics Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2014-03-281617440050

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