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: | 2 |
Pharmacology for NDA: 218590
| Mechanism of Action | Opioid Antagonists |
Suppliers and Packaging for NDA: 218590
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZURNAI (AUTOINJECTOR) | nalmefene hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 218590 | NDA | Purdue Pharma L.P. | 59011-962 | 59011-962-01 | 1 SYRINGE, GLASS in 1 CARTON (59011-962-01) / .5 mL in 1 SYRINGE, GLASS |
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: | ⤷ Start Trial | Patent Expiration: | Nov 5, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Start Trial | Patent Expiration: | Nov 5, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATING OPIOID OVERDOSE | ||||||||
Expired US Patents for NDA 218590
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