BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE
Summary
FDA approved BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE by ACTAVIS LABS UT INC. NDA (New Drug) approval (REMS) on 2026-06-18. CAPSULE, ORAL.
Details
Source
Drug Approval
External ID
NDA020232-53
Action Date
2026-06-18
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE, CAPSULE, ORAL. Application: NDA020232
Company
Context & Analysis
ACTAVIS LABS UT INC has 5 FDA actions in our database.
Frequently Asked Questions
How often does ACTAVIS LABS UT INC have FDA actions?
ACTAVIS LABS UT INC has 5 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 "NDA020232-53" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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