Details for New Drug Application (NDA): 209862
✉ Email this page to a colleague
NDA 209862 describes EVZIO (AUTOINJECTOR), which is a drug marketed by Kaleo Inc and is included in one NDA. It is available from one supplier. There are thirty-three patents protecting this drug. Additional details are available on the EVZIO (AUTOINJECTOR) profile page.
The generic ingredient in EVZIO (AUTOINJECTOR) is naloxone hydrochloride. There are twelve drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride profile page.
The generic ingredient in EVZIO (AUTOINJECTOR) is naloxone hydrochloride. There are twelve drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride profile page.
Summary for 209862
| Tradename: | EVZIO (AUTOINJECTOR) |
| Applicant: | Kaleo Inc |
| Ingredient: | naloxone hydrochloride |
| Patents: | 33 |
Pharmacology for NDA: 209862
| Mechanism of Action | Opioid Antagonists |
Medical Subject Heading (MeSH) Categories for 209862
Suppliers and Packaging for NDA: 209862
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EVZIO (AUTOINJECTOR) | naloxone hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 209862 | NDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1495 | 51662-1495-1 | 2 DOSE PACK in 1 CARTON (51662-1495-1) / .4 mL in 1 DOSE PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | Strength | 2MG/0.4ML (2MG/0.4ML) | ||||
| Approval Date: | Oct 19, 2016 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | May 24, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | USE OF A DELIVERY DEVICE TO DELIVER A DOSE OF NALOXONE | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Mar 20, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | USE OF A DELIVERY DEVICE TO DELIVER A BIOEQUIVALENT DOSE OF A NALOXONE COMPOSITION VIA A NEEDLE | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Nov 23, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Complete Access Available with Subscription
