Details for New Drug Application (NDA): 209862

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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-five 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

Narcotic Antagonists

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:	⤷ Subscribe	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:	⤷ Subscribe	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:	⤷ Subscribe	Patent Expiration:	Nov 23, 2024	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 209862

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016	8,361,029	⤷ Subscribe
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016	9,737,669	⤷ Subscribe
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016	10,314,977	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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