Naloxone Auto-Injector

Brand(s)
Evzio
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Kaleo, Inc. (2014-04-07)
Oldest Current Product
2014-04-03
License(s)
NDA
RxNORM
AUTO-INJECTOR\NALOXONE
FDAOB
INTRAMUSCULAR, SUBCUTANEOUS\SOLUTION\NALOXONE HYDROCHLORIDE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\NALOXONE HYDROCHLORIDE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\NALOXONE

product(s) by strength(s)

0.4 ml naloxone hydrochloride 1 mg/ml auto-injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1608420030EvzioNDAKaleo, Inc.2014-04-03NALOXONE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONNDA205787df501ed0-c0f4-11e3-8a33-0800200c9a66

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA205787EVZIOKALEO INC2014-04-03p8231573, SUBSTANCE
p8016788, SUBSTANCE
p9022022, SUBSTANCE
p8021344, SUBSTANCE
p7731690, SUBSTANCE
p8313466, SUBSTANCE
p8226610, SUBSTANCE
p7918823, SUBSTANCE
p8425462, SUBSTANCE
p7731686, SUBSTANCE
p8361029, SUBSTANCE
p8939943, SUBSTANCE
p7749194, SUBSTANCE
p8926594, SUBSTANCE
p9056170, SUBSTANCE
p8627816, SUBSTANCE
p8608698, SUBSTANCE
p7947017, SUBSTANCE
p8206360, SUBSTANCE
NDA205787_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA205787_001RXNALOXONE HYDROCHLORIDE (0.4MG/0.4ML)SOLUTIONTrue2014-04-03EVZIO

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p7731686 (view patent)2026-06-01NDA205787, NDA201739Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
Epinephrine Injectable Solution
2p7731690 (view patent)2025-01-15NDA205787, NDA201739Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
Epinephrine Injectable Solution
3p7749194 (view patent)2028-10-30NDA205787, NDA201739Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
Epinephrine Injectable Solution
4p7918823 (view patent)2024-11-23NDA205787, NDA201739Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
Epinephrine Injectable Solution
5p7947017 (view patent)2028-03-12NDA205787, NDA201739Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
Epinephrine Injectable Solution
6p8016788 (view patent)2025-03-21NDA205787, NDA201739Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
Epinephrine Injectable Solution
7p8021344 (view patent)2029-11-02NDA205787, NDA201739Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
Epinephrine Injectable Solution
8p8206360 (view patent)2027-02-27NDA205787, NDA201739Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
Epinephrine Injectable Solution
9p8226610 (view patent)2029-04-10NDA205787, NDA201739Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
Epinephrine Injectable Solution
10p8231573 (view patent)2028-11-25NDA205787, NDA201739Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
Epinephrine Injectable Solution
11p8313466 (view patent)2024-11-23NDA205787, NDA201739Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
Epinephrine Injectable Solution
12p8361029 (view patent)2024-11-23NDA205787, NDA201739Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
Epinephrine Injectable Solution
13p8425462 (view patent)2024-11-23NDA205787, NDA201739Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
Epinephrine Injectable Solution
14p8608698 (view patent)2024-11-23NDA205787, NDA201739Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
Epinephrine Injectable Solution
15p8627816 (view patent)2032-02-04NDA205787
16p8926594 (view patent)2026-03-31NDA205787, NDA201739Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
Epinephrine Injectable Solution
17p8939943 (view patent)2031-02-28NDA205787
18p9022022 (view patent)2031-02-28NDA205787
19p9056170 (view patent)2024-11-23NDA205787, NDA201739Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
Epinephrine Injectable Solution

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1df501ed0-c0f4-11e3-8a33-0800200c9a66 (view SPL)These highlights do not include all the information needed to use EVZIO safely and effectively. See full prescribing information for EVZIO. EVZIO (naloxone hydrochloride injection) Auto-Injector for intramuscular or subcutaneous use Initial U.S. Approval: 1971prescriptionHuman PrescriptionKaleo, Inc.2014-04-071608420030

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