PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE)
Summary
FDA approved PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) by HOSPIRA. NDA (New Drug) approval (Labeling) on 2026-05-01. INJECTABLE, INJECTION.
Details
Source
Drug Approval
External ID
NDA021038-61
Action Date
2026-05-01
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
PRECEDEX (generic: DEXMEDETOMIDINE HYDROCHLORIDE), INJECTABLE, INJECTION. Application: NDA021038
Company
Context & Analysis
HOSPIRA has 52 FDA actions in our database.
Frequently Asked Questions
How often does HOSPIRA have FDA actions?
HOSPIRA has 52 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 "NDA021038-61" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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