TRAMADOL HYDROCHLORIDE
Summary
FDA approved TRAMADOL HYDROCHLORIDE by CSPC OUYI PHARM CO. ANDA (Generic) approval (REMS) on 2026-06-18. TABLET, ORAL.
Details
Source
Drug Approval
External ID
ANDA091498-17
Action Date
2026-06-18
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
TRAMADOL HYDROCHLORIDE, TABLET, ORAL. Application: ANDA091498
Company
Context & Analysis
Frequently Asked Questions
How often does CSPC OUYI PHARM CO have FDA actions?
This is the only FDA action we have on record for CSPC OUYI PHARM CO in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "ANDA091498-17" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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