remifentanil Injectable Solution

Brand(s)
Ultiva
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Institutional Llc (2013-12-31)
Oldest Current Product
1996-11-06
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\REMIFENTANIL
FDAOB
INJECTION\INJECTION\REMIFENTANIL HYDROCHLORIDE\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\REMIFENTANIL HYDROCHLORIDE
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\REMIFENTANIL

product(s) by strength(s)

remifentanil 1 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1674570198UltivaNDAMylan Institutional Llc1996-11-06REMIFENTANIL HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA020630dbc63b6e-f8c5-4fd0-8ec3-4f5e19125313

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA020630ULTIVAMYLAN INSTITUTIONAL LLC1996-07-12p5866591, SUBSTANCENDA020630_001, NDA020630_002, NDA020630_003

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA020630_001RXREMIFENTANIL HYDROCHLORIDE (EQ 1MG BASE/VIAL)INJECTIONFalse1996-07-12ULTIVA
2NDA020630_002RXREMIFENTANIL HYDROCHLORIDE (EQ 2MG BASE/VIAL)INJECTIONFalse1996-07-12ULTIVA
3NDA020630_003RXREMIFENTANIL HYDROCHLORIDE (EQ 5MG BASE/VIAL)INJECTIONTrue1996-07-12ULTIVA

patent(s)

#idexpiration dateapplication(s)
1p5866591 (view patent)2017-09-10NDA020630

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1dbc63b6e-f8c5-4fd0-8ec3-4f5e19125313 (view SPL)prescriptionHuman PrescriptionMylan Institutional Llc2013-12-315674570198

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