HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Summary
FDA approved HYDROCODONE BITARTRATE AND ACETAMINOPHEN by AUROLIFE PHARMA LLC. ANDA (Generic) approval (REMS) on 2026-06-18. TABLET, ORAL.
Details
Source
Drug Approval
External ID
ANDA201013-23
Action Date
2026-06-18
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, TABLET, ORAL. Application: ANDA201013
Company
Context & Analysis
AUROLIFE PHARMA LLC has 10 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
How often does AUROLIFE PHARMA LLC have FDA actions?
AUROLIFE PHARMA LLC has 10 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "ANDA201013-23" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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