Alfentanil Injectable Solution

Brand(s)
Alfenta
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Akorn (2013-07-17)
Oldest Current Product
1999-10-28
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\ALFENTANIL
FDAOB
INJECTION\INJECTION\ALFENTANIL HYDROCHLORIDE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\ALFENTANIL HYDROCHLORIDE
INTRAVENOUS\INJECTION\ALFENTANIL HYDROCHLORIDE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\ALFENTANIL
INTRAVENOUS\INJECTION\ALFENTANIL

product(s) by strength(s)

alfentanil 0.5 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1174780841NDAAkorn2013-07-19ALFENTANIL HYDROCHLORIDEINTRAVENOUSINJECTIONNDA019353c965d63f-933b-4a83-88f6-c8c74159530b

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004092266ANDAHospira, Inc.1999-10-28, 2005-08-30ALFENTANIL HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA0752219781f06d-485e-41f0-84aa-ee177f0ad137, d50273f5-46c0-45cf-8385-0d3bab91b87c

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA075221ALFENTANILHOSPIRA INC1999-10-28ANDA075221_001
2NDA019353ALFENTAAKORN INC1986-12-29NDA019353_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA075221_001RXALFENTANIL HYDROCHLORIDE (EQ 0.5MG BASE/ML)INJECTIONFalseAP1999-10-28ALFENTANIL
2NDA019353_001RXALFENTANIL HYDROCHLORIDE (EQ 0.5MG BASE/ML)INJECTIONTrueAP1986-12-29ALFENTA

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1098af6c6-7400-4b2b-bae6-03d5913ad712 (view SPL)ALFENTAprescriptionHuman PrescriptionAkornANALYSIS, MANUFACTURE, REPACK2010-01-214174780067
29781f06d-485e-41f0-84aa-ee177f0ad137 (view SPL)ALFENTANILINJECTION, USPprescriptionHuman PrescriptionHospira, Inc.2014-08-0311004092266
3c965d63f-933b-4a83-88f6-c8c74159530b (view SPL)Alfentanil HCl Injection, USPprescriptionHuman PrescriptionAkornANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2013-07-171174780841
4d50273f5-46c0-45cf-8385-0d3bab91b87c (view SPL)ALFENTANIL INJECTION USPprescriptionHuman PrescriptionHospira, Inc.analysis, api manufacture, manufacture2014-08-031004092266

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