TRAMADOL HYDROCHLORIDE
Summary
FDA approved TRAMADOL HYDROCHLORIDE by ACTAVIS ELIZABETH. ANDA (Generic) approval (REMS) on 2026-06-18. TABLET, EXTENDED RELEASE, ORAL.
Details
Source
Drug Approval
External ID
ANDA091609-17
Action Date
2026-06-18
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
TRAMADOL HYDROCHLORIDE, TABLET, EXTENDED RELEASE, ORAL. Application: ANDA091609
Company
Context & Analysis
ACTAVIS ELIZABETH has 19 FDA actions in our database.
Frequently Asked Questions
How often does ACTAVIS ELIZABETH have FDA actions?
ACTAVIS ELIZABETH has 19 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 "ANDA091609-17" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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