HYDROCODONE BITARTRATE AND IBUPROFEN
Summary
FDA approved HYDROCODONE BITARTRATE AND IBUPROFEN by ANI PHARMS. ANDA (Generic) approval (REMS) on 2026-06-18. TABLET, ORAL.
Details
Source
Drug Approval
External ID
ANDA077454-13
Action Date
2026-06-18
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
HYDROCODONE BITARTRATE AND IBUPROFEN, TABLET, ORAL. Application: ANDA077454
Company
Context & Analysis
ANI PHARMS has 27 FDA actions in our database.
Frequently Asked Questions
How often does ANI PHARMS have FDA actions?
ANI PHARMS has 27 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 "ANDA077454-13" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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