OXYCODONE AND ACETAMINOPHEN
Summary
FDA approved OXYCODONE AND ACETAMINOPHEN by NOVEL LABS INC. ANDA (Generic) approval (REMS) on 2026-06-18. TABLET, ORAL.
Details
Source
Drug Approval
External ID
ANDA204407-16
Action Date
2026-06-18
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
OXYCODONE AND ACETAMINOPHEN, TABLET, ORAL. Application: ANDA204407
Company
Context & Analysis
NOVEL LABS INC has 13 FDA actions in our database.
Frequently Asked Questions
How often does NOVEL LABS INC have FDA actions?
NOVEL LABS INC has 13 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 "ANDA204407-16" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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