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Last Updated: November 2, 2024

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-three 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 ActionOpioid Antagonists
Medical Subject Heading (MeSH) Categories for 215457
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:DISCNDosage:SOLUTION;INTRAMUSCULAR, SUBCUTANEOUSStrength10MG/0.4ML (10MG/0.4ML)
Approval Date:Feb 28, 2022TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:May 24, 2031Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF A DELIVERY DEVICE TO DELIVER A DOSE OF NALOXONE
Patent:⤷  Sign UpPatent Expiration:Nov 23, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Feb 28, 2031Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF A DELIVERY DEVICE TO ADMINISTER A DOSE OF NALOXONE

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