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)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 608420030 | Evzio | NDA | Kaleo, Inc. | 2014-04-03 | NALOXONE HYDROCHLORIDE | INTRAMUSCULAR | INJECTION, SOLUTION | NDA205787 | df501ed0-c0f4-11e3-8a33-0800200c9a66 |
application(s)
| # | id | title | applicant | approved | patent | approved drug |
|---|---|---|---|---|---|---|
| 1 | NDA205787 | EVZIO | KALEO INC | 2014-04-03 | p8231573, 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)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|
| 1 | NDA205787_001 | RX | NALOXONE HYDROCHLORIDE (0.4MG/0.4ML) | SOLUTION | True | 2014-04-03 | EVZIO |
patent(s)
spl(s)
| # | id | title | category | type | labeler | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|
| 1 | df501ed0-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: 1971 | prescription | Human Prescription | Kaleo, Inc. | 2014-04-07 | 1 | 608420030 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII