Details for New Drug Application (NDA): 215457

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NDA 215457 describes NALOXONE HYDROCHLORIDE (AUTOINJECTOR), which is a drug marketed by Kaleo Inc and is included in one NDA. It is available from one supplier. There are eighteen patents protecting this drug. Additional details are available on the NALOXONE HYDROCHLORIDE (AUTOINJECTOR) profile page.

The generic ingredient in NALOXONE HYDROCHLORIDE (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 215457

Tradename:	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)
Applicant:	Kaleo Inc
Ingredient:	naloxone hydrochloride
Patents:	18

Pharmacology for NDA: 215457

Mechanism of Action	Opioid Antagonists

Medical Subject Heading (MeSH) Categories for 215457

Narcotic Antagonists

Suppliers and Packaging for NDA: 215457

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	215457	NDA	Kaleo, Inc.	60842-002	60842-002-02	10 DOSE PACK in 1 CARTON (60842-002-02) / .4 mL in 1 DOSE PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS			Strength	10MG/0.4ML (10MG/0.4ML)
Approval Date:	Feb 28, 2022	TE:		RLD:	Yes
Patent:	10,143,792	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:	10,314,977	Patent Expiration:	Nov 23, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	10,322,239	Patent Expiration:	Feb 28, 2031	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	USE OF A DELIVERY DEVICE TO ADMINISTER A DOSE OF NALOXONE

Expired US Patents for NDA 215457

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kaleo Inc	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	215457-001	Feb 28, 2022	8,361,029	⤷ Subscribe
Kaleo Inc	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	215457-001	Feb 28, 2022	9,737,669	⤷ Subscribe
Kaleo Inc	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	215457-001	Feb 28, 2022	10,314,977	⤷ Subscribe
Kaleo Inc	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	215457-001	Feb 28, 2022	8,608,698	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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