Sufentanil Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Akorn (2014-03-31)
Oldest Current Product
1995-12-15
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\SUFENTANIL
FDAOB
INJECTION\INJECTION\SUFENTANIL CITRATE\rdfq
SPL Active
EPIDURAL\INJECTION, SOLUTION\SUFENTANIL CITRATE
EPIDURAL\INJECTION\SUFENTANIL CITRATE
SPL Moiety
EPIDURAL\INJECTION, SOLUTION\SUFENTANIL
EPIDURAL\INJECTION\SUFENTANIL

product(s) by strength(s)

sufentanil 0.05 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1174780050NDAAkorn2010-12-01SUFENTANIL CITRATEEPIDURALINJECTIONNDA01905095e639db-1ca3-4328-b347-7ea348f6cc72

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004093380ANDAHospira, Inc.1996-12-11SUFENTANIL CITRATEEPIDURALINJECTION, SOLUTIONANDA07453420293943-46ff-4345-1aa4-929b4e017a25
2004093382ANDAHospira, Inc.1996-12-11SUFENTANIL CITRATEEPIDURALINJECTION, SOLUTIONANDA07453420293943-46ff-4345-1aa4-929b4e017a25
3006416110ANDAWest-Ward Pharmaceuticals Corp.1995-12-15SUFENTANIL CITRATEEPIDURALINJECTIONANDA07441352fc28b9-464a-4173-9d0d-000ed0dbf265
4006416111ANDAWest-Ward Pharmaceuticals Corp.1995-12-15SUFENTANIL CITRATEEPIDURALINJECTIONANDA07441352fc28b9-464a-4173-9d0d-000ed0dbf265
5006416112ANDAWest-Ward Pharmaceuticals Corp.1995-12-15SUFENTANIL CITRATEEPIDURALINJECTIONANDA07441352fc28b9-464a-4173-9d0d-000ed0dbf265

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074406SUFENTANIL CITRATETrueWATSON LABORATORIES INC1995-12-15ANDA074406_001
2ANDA074413SUFENTANIL CITRATEEUROHEALTH INTERNATIONAL SARL1995-12-15ANDA074413_001
3ANDA074534SUFENTANIL CITRATEHOSPIRA INC1996-12-11ANDA074534_001
4NDA019050SUFENTA PRESERVATIVE FREEAKORN INC1984-05-04NDA019050_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA074406_001discontinuedSUFENTANIL CITRATE (EQ 0.05MG BASE/ML)INJECTIONFalse1995-12-15SUFENTANIL CITRATE
2ANDA074413_001RXSUFENTANIL CITRATE (EQ 0.05MG BASE/ML)INJECTIONFalseAP1995-12-15SUFENTANIL CITRATE
3ANDA074534_001RXSUFENTANIL CITRATE (EQ 0.05MG BASE/ML)INJECTIONFalseAP1996-12-11SUFENTANIL CITRATE
4NDA019050_001RXSUFENTANIL CITRATE (EQ 0.05MG BASE/ML)INJECTIONTrueAP1984-05-04SUFENTA PRESERVATIVE FREE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
120293943-46ff-4345-1aa4-929b4e017a25 (view SPL)prescriptionHuman PrescriptionHospira, Inc.2015-02-1011004093380, 004093382
252fc28b9-464a-4173-9d0d-000ed0dbf265 (view SPL)Sufentanil Citrate Injection, USPCIIRx onlyprescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.ANALYSIS, LABEL, MANUFACTURE2012-05-164006416110, 006416111, 006416112
395e639db-1ca3-4328-b347-7ea348f6cc72 (view SPL)SUFENTANIL CITRATEINJECTION, USPCIIprescriptionHuman PrescriptionAkornANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2014-03-313174780050

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