BUPHENYL (SODIUM PHENYLBUTYRATE)
Summary
FDA approved BUPHENYL (SODIUM PHENYLBUTYRATE) by HORIZON THERAP US. NDA (New Drug) approval (Labeling) on 2022-07-29. TABLET, ORAL.
Details
Source
Drug Approval
External ID
NDA020572-25
Action Date
2022-07-29
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
BUPHENYL (generic: SODIUM PHENYLBUTYRATE), TABLET, ORAL. Application: NDA020572
Company
Context & Analysis
HORIZON THERAP US has 3 FDA actions in our database.
Frequently Asked Questions
How often does HORIZON THERAP US have FDA actions?
HORIZON THERAP US has 3 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 "NDA020572-25" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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