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Last Updated: October 31, 2024

Details for New Drug Application (NDA): 218590


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NDA 218590 describes ZURNAI (AUTOINJECTOR), which is a drug marketed by Purdue Pharma Lp and is included in one NDA. There are twenty-one patents protecting this drug. Additional details are available on the ZURNAI (AUTOINJECTOR) profile page.

The generic ingredient in ZURNAI (AUTOINJECTOR) is nalmefene hydrochloride. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the nalmefene hydrochloride profile page.
Summary for 218590
Tradename:ZURNAI (AUTOINJECTOR)
Applicant:Purdue Pharma Lp
Ingredient:nalmefene hydrochloride
Patents:21

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAMUSCULAR, SUBCUTANEOUSStrengthEQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)
Approval Date:Aug 7, 2024TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jul 31, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Aug 21, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Jan 24, 2026Product Flag?YSubstance Flag?Delist Request?

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