MIRALAX (POLYETHYLENE GLYCOL 3350)
Summary
FDA approved MIRALAX (POLYETHYLENE GLYCOL 3350) by BAYER HEALTHCARE LLC. NDA (New Drug) approval (Labeling) on 2025-02-03. FOR SOLUTION, ORAL.
Details
Source
Drug Approval
External ID
NDA022015-50
Action Date
2025-02-03
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
MIRALAX (generic: POLYETHYLENE GLYCOL 3350), FOR SOLUTION, ORAL. Application: NDA022015
Company
Context & Analysis
BAYER HEALTHCARE LLC has 4 FDA actions in our database.
Frequently Asked Questions
How often does BAYER HEALTHCARE LLC have FDA actions?
BAYER HEALTHCARE LLC has 4 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 "NDA022015-50" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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