DEXTROSE (DEXTROSE MONOHYDRATE)
Summary
FDA approved DEXTROSE (DEXTROSE MONOHYDRATE) by OTSUKA ICU MEDCL. NDA (New Drug) approval (Labeling) on 2025-06-09. INJECTABLE, INJECTION.
Details
Source
Drug Approval
External ID
NDA018080-122
Action Date
2025-06-09
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
DEXTROSE (generic: DEXTROSE MONOHYDRATE), INJECTABLE, INJECTION. Application: NDA018080
Company
Context & Analysis
OTSUKA ICU MEDCL has 2 FDA actions in our database.
Frequently Asked Questions
How often does OTSUKA ICU MEDCL have FDA actions?
OTSUKA ICU MEDCL 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 "NDA018080-122" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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