HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Summary
FDA approved HYDROCODONE BITARTRATE AND ACETAMINOPHEN by UPSHER SMITH LABS. ANDA (Generic) approval (REMS) on 2026-06-18. TABLET, ORAL.
Details
Source
Drug Approval
External ID
ANDA206484-10
Action Date
2026-06-18
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, TABLET, ORAL. Application: ANDA206484
Company
Context & Analysis
UPSHER SMITH LABS has 12 FDA actions in our database.
Frequently Asked Questions
How often does UPSHER SMITH LABS have FDA actions?
UPSHER SMITH LABS has 12 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 "ANDA206484-10" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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