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.
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 | |||||
| Regulatory Exclusivity Expiration: | Aug 7, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | 10,279,131 | Patent Expiration: | Jul 31, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 10,357,609 | Patent Expiration: | Aug 21, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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