FIORICET WITH CODEINE (BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE)
Summary
FDA approved FIORICET WITH CODEINE (BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE) by LGM PHARMA. ANDA (Generic) approval (REMS) on 2026-06-18. CAPSULE, ORAL.
Details
Source
Drug Approval
External ID
ANDA076560-13
Action Date
2026-06-18
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
FIORICET WITH CODEINE (generic: BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE), CAPSULE, ORAL. Application: ANDA076560
Company
Context & Analysis
LGM PHARMA has 2 FDA actions in our database.
Frequently Asked Questions
How often does LGM PHARMA have FDA actions?
LGM PHARMA has 2 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 "ANDA076560-13" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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