RYANODEX DANTROLENE SODIUM (DANTROLENE SODIUM)
Summary
FDA approved RYANODEX DANTROLENE SODIUM (DANTROLENE SODIUM) by EAGLE PHARMS. NDA (New Drug) approval (Labeling) on 2024-04-02. FOR SUSPENSION, INTRAVENOUS.
Details
Source
Drug Approval
External ID
NDA205579-11
Action Date
2024-04-02
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
RYANODEX DANTROLENE SODIUM (generic: DANTROLENE SODIUM), FOR SUSPENSION, INTRAVENOUS. Application: NDA205579
Company
Context & Analysis
EAGLE PHARMS has 3 FDA actions in our database.
Frequently Asked Questions
How often does EAGLE PHARMS have FDA actions?
EAGLE PHARMS has 3 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 "NDA205579-11" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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