Details for New Drug Application (NDA): 218590
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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: | RX | Dosage: | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | Strength | EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML) | ||||
Approval Date: | Aug 7, 2024 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jul 31, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 21, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 24, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? |
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