ULTIVA (REMIFENTANIL HYDROCHLORIDE)
Summary
FDA approved ULTIVA (REMIFENTANIL HYDROCHLORIDE) by MYLAN INSTITUTIONAL. NDA (New Drug) approval (Labeling) on 2025-12-22. INJECTABLE, INJECTION.
Details
Source
Drug Approval
External ID
NDA020630-33
Action Date
2025-12-22
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
ULTIVA (generic: REMIFENTANIL HYDROCHLORIDE), INJECTABLE, INJECTION. Application: NDA020630
Company
Context & Analysis
MYLAN INSTITUTIONAL has 7 FDA actions in our database.
Frequently Asked Questions
How often does MYLAN INSTITUTIONAL have FDA actions?
MYLAN INSTITUTIONAL has 7 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 "NDA020630-33" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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