Dexmedetomidine Injection

Brand(s)
Precedex
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira, Inc. (2015-08-18)
Oldest Current Product
2013-03-13
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
INJECTION\DEXMEDETOMIDINE
FDAOB
INJECTION\INJECTION\DEXMEDETOMIDINE HYDROCHLORIDE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\DEXMEDETOMIDINE HYDROCHLORIDE
INTRAVENOUS\INJECTION, SOLUTION\DEXMEDETOMIDINE HYDROCHLORIDE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\DEXMEDETOMIDINE
INTRAVENOUS\INJECTION, SOLUTION\DEXMEDETOMIDINE

product(s) by strength(s)

dexmedetomidine 0.004 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004091660PrecedexNDAHospira, Inc.2013-03-13DEXMEDETOMIDINE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONNDA021038548a88c0-afda-427e-75ac-5af0cfa2224c

2 ml dexmedetomidine 0.1 mg/ml injection

original product(s)(s)

#idlabeleractive ingredient(s)routedose formspl
1633230421App Pharmaceuticals, LlcDEXMEDETOMIDINE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONc1b8eb58-596b-481d-beb6-ba9d2237abf4

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007813353NDA AUTHORIZED GENERICSandoz Inc2014-10-03DEXMEDETOMIDINE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTION, CONCENTRATENDA0210385348515d-7e6b-432c-9a98-6ec8103e2cad
2174780055ANDAAkorn2014-11-24DEXMEDETOMIDINE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTION, CONCENTRATEANDA2025858fb7886c-7762-4b72-989b-0fe8e963b4b8
3420230146ANDAPar Pharmaceutical Inc.2014-08-19DEXMEDETOMIDINE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTION, CONCENTRATEANDA2039721ee59985-4c1d-48f7-b8f9-5584c2d55e08
4576640596ANDACaraco Pharmaceutical Laboratories, Ltd.2015-04-08DEXMEDETOMIDINE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA2021264fe788bc-4ad1-4b32-83d3-dcbfcd8429aa
5674570251ANDAMylan Institutional Llc2014-08-18DEXMEDETOMIDINE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTION, CONCENTRATEANDA202881ebdfe2e8-30ca-4f18-935a-41bcbbce4937
6674570580ANDAMylan Institutional Llc2015-06-09DEXMEDETOMIDINE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTION, CONCENTRATEANDA2028813aeeb817-ba11-4eb9-be6b-f9acc12a7e9b
7674570581ANDAMylan Institutional Llc2015-06-02DEXMEDETOMIDINE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTION, CONCENTRATEANDA202881ebdfe2e8-30ca-4f18-935a-41bcbbce4937

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1ANDA201072DEXMEDETOMIDINE HYDROCHLORIDEFRESENIUS KABI USA LLC2015-09-18ANDA201072_001
2ANDA202126DEXMEDETOMIDINE HYDROCHLORIDESUN PHARMACEUTICAL INDUSTRIES INC2015-08-20ANDA202126_001
3ANDA202585DEXMEDETOMIDINE HYDROCHLORIDEAKORN INC2014-11-24ANDA202585_001
4ANDA202881DEXMEDETOMIDINE HYDROCHLORIDEMYLAN INSTITUTIONAL LLC2014-08-18ANDA202881_001
5ANDA203972DEXMEDETOMIDINE HYDROCHLORIDEPAR STERILE PRODUCTS LLC2014-08-18ANDA203972_001
6NDA021038PRECEDEXHOSPIRA INC1999-12-17p6716867, INTENSIVE CARE UNIT SEDATION
p8455527, USE FOR SEDATION
p8338470, SUBSTANCE
p8648106, SUBSTANCE
p8242158, SUBSTANCE
PEDIATRIC EXCLUSIVITY [2016-12-17]
REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST [2016-06-17]
NDA021038_001, NDA021038_002, NDA021038_003, NDA021038_004

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA201072_001RXDEXMEDETOMIDINE HYDROCHLORIDE (EQ 200MCG BASE/2ML)INJECTIONFalseAP2015-09-18DEXMEDETOMIDINE HYDROCHLORIDE
2ANDA202126_001RXDEXMEDETOMIDINE HYDROCHLORIDE (EQ 200MCG BASE/2ML)INJECTIONFalseAP2015-08-20DEXMEDETOMIDINE HYDROCHLORIDE
3ANDA202585_001RXDEXMEDETOMIDINE HYDROCHLORIDE (EQ 200MCG BASE/2ML)INJECTIONFalseAP2014-11-24DEXMEDETOMIDINE HYDROCHLORIDE
4ANDA202881_001RXDEXMEDETOMIDINE HYDROCHLORIDE (EQ 200MCG BASE/2ML)INJECTIONFalseAP2014-08-18DEXMEDETOMIDINE HYDROCHLORIDE
5ANDA203972_001RXDEXMEDETOMIDINE HYDROCHLORIDE (EQ 200MCG BASE/2ML)INJECTIONFalseAP2014-08-18DEXMEDETOMIDINE HYDROCHLORIDE
6NDA021038_001RXDEXMEDETOMIDINE HYDROCHLORIDE (EQ 200MCG BASE/2ML)INJECTIONTrueAP1999-12-17PRECEDEX
7NDA021038_002RXDEXMEDETOMIDINE HYDROCHLORIDE (EQ 200MCG BASE/50ML)INJECTIONTrue2013-03-13PRECEDEX
8NDA021038_003RXDEXMEDETOMIDINE HYDROCHLORIDE (EQ 400MCG BASE/100ML)INJECTIONTrue2013-03-13PRECEDEX
9NDA021038_004RXDEXMEDETOMIDINE HYDROCHLORIDE (EQ 80MCG BASE/20ML)INJECTIONFalse2014-11-14PRECEDEX

patent(s)

#idexpiration dateapplication(s)
1p6716867 (view patent)2019-03-31NDA021038
2p8242158 (view patent)2032-01-04NDA021038
3p8338470 (view patent)2032-01-04NDA021038
4p8455527 (view patent)2032-01-04NDA021038
5p8648106 (view patent)2032-01-04NDA021038

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11ee59985-4c1d-48f7-b8f9-5584c2d55e08 (view SPL)These highlights do not include all the information needed to use DEXMEDETOMIDINE HYDROCHLORIDE safely and effectively. See full prescribing information for DEXMEDETOMIDINE HYDROCHLORIDE INJECTION. DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, Concentrate For intravenous infusion of injection following dilution of concentrate Initial U.S. Approval: 1999prescriptionHuman PrescriptionPar Pharmaceutical Inc.2015-07-233420230146
23aeeb817-ba11-4eb9-be6b-f9acc12a7e9b (view SPL)These highlights do not include all the information needed to use dexmedetomidine hydrochloride injection safely and effectively. See full prescribing information for dexmedetomidine hydrochloride injection.DEXMEDETOMIDINE hydrochloride injection for intravenous useInitial U.S. Approval: 1999prescriptionHuman PrescriptionMylan Institutional Llc2014-12-316674570580
34fe788bc-4ad1-4b32-83d3-dcbfcd8429aa (view SPL)These highlights do not include all the information needed to use DEXMEDETOMIDINE hydrochloride injection safely and effectively. See full prescribing information forDEXMEDETOMIDINE hydrochloride injection. DEXMEDETOMIDINEhydrochloride injection,For intravenous useInitial U.S. Approval: 1999prescriptionHuman PrescriptionCaraco Pharmaceutical Laboratories, Ltd.MANUFACTURE2015-06-082576640596
45348515d-7e6b-432c-9a98-6ec8103e2cad (view SPL)These highlights do not include all the information needed to use DEXMEDETOMIDINE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE HYDROCHLORIDE INJECTION.DEXMEDETOMIDINE HYDROCHLORIDE INJECTION For intravenous use. Initial U.S. Approval: 1999prescriptionHuman PrescriptionSandoz Inc2015-04-232007813353
5548a88c0-afda-427e-75ac-5af0cfa2224c (view SPL)These highlights do not include all the information needed to use PRECEDEX safely and effectively. See full prescribing information for PRECEDEX. PrecedexTM (dexmedetomidine hydrochloride) Injection For intravenous use. PrecedexTM (dexmedetomidine hydrochloride) in 0.9% Sodium Chloride Injection Initial U.S. Approval: 1999prescriptionHuman PrescriptionHospira, Inc.2015-08-1827004091660, 004091638
68fb7886c-7762-4b72-989b-0fe8e963b4b8 (view SPL)These highlights do not include all the information needed to use Dexmedetomidine Hydrochloride Injection safely and effectively. See full prescribing information for Dexmedetomidine Hydrochloride Injection.Dexmedetomidine Hydrochloride Injection, concentrate For intravenous infusion of injection following dilution of concentrate Initial U.S. Approval: 1999prescriptionHuman PrescriptionAkornANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2014-08-311174780055
7c1b8eb58-596b-481d-beb6-ba9d2237abf4 (view SPL)These highlights do not include all the information needed to use Dexmedetomidine Hydrochloride Injection safely and effectively. See full prescribing information for Dexmedetomidine Hydrochloride Injection. Dexmedetomidine Hydrochloride InjectionFor intravenous use.Initial U.S. Approval: 1999prescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-12-121633230421
8ebdfe2e8-30ca-4f18-935a-41bcbbce4937 (view SPL)These highlights do not include all the information needed to use dexmedetomidine hydrochloride injection safely and effectively. See full prescribing information for dexmedetomidine hydrochloride injection.DEXMEDETOMIDINE hydrochloride injection for intravenous useInitial U.S. Approval: 1999prescriptionHuman PrescriptionMylan Institutional Llc2014-12-177674570251, 674570581

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