HYDROCODONE BITARTRATE
Summary
FDA approved HYDROCODONE BITARTRATE by ALVOGEN. ANDA (Generic) approval (REMS) on 2026-06-18. TABLET, EXTENDED RELEASE, ORAL.
Details
Source
Drug Approval
External ID
ANDA208269-5
Action Date
2026-06-18
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
HYDROCODONE BITARTRATE, TABLET, EXTENDED RELEASE, ORAL. Application: ANDA208269
Company
Context & Analysis
ALVOGEN has 7 FDA actions in our database.
Frequently Asked Questions
How often does ALVOGEN have FDA actions?
ALVOGEN has 7 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 "ANDA208269-5" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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