OPVEE (NALMEFENE HYDROCHLORIDE)
Summary
FDA approved OPVEE (NALMEFENE HYDROCHLORIDE) by INDIVIOR. NDA (New Drug) approval (Type 3 - New Dosage Form) on 2023-05-22. SPRAY, NASAL.
Details
Source
Drug Approval
External ID
NDA217470-1
Action Date
2023-05-22
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
OPVEE (generic: NALMEFENE HYDROCHLORIDE), SPRAY, NASAL. Application: NDA217470
Company
Context & Analysis
INDIVIOR has 2 FDA actions in our database.
Frequently Asked Questions
How often does INDIVIOR have FDA actions?
INDIVIOR has 2 FDA actions in our database, including 0 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA217470-1" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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