APPLICATION
ANDA216843
TYPE
ANDA
ORIGINAL APPROVAL
2023-01-24
LATEST ACTION
2025-09-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
ALVIMOPANPrescription
ALVIMOPAN 12MG · CAPSULE · ORAL
Approval history
2023-06-12REMS · Supplement 1AP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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