TRAMADOL HYDROCHLORIDE
Summary
FDA approved TRAMADOL HYDROCHLORIDE by ROSEMONT. NDA (New Drug) approval (REMS) on 2026-06-18. SOLUTION, ORAL.
Details
Source
Drug Approval
External ID
NDA214044-5
Action Date
2026-06-18
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
TRAMADOL HYDROCHLORIDE, SOLUTION, ORAL. Application: NDA214044
Company
Context & Analysis
Frequently Asked Questions
How often does ROSEMONT have FDA actions?
This is the only FDA action we have on record for ROSEMONT in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA214044-5" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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