FDA ANDA · ANDA221049
LUBIPROSTONE
Sponsor: HUMANWELL PURACAP
What this page does not claim
A drug page is a reference view of public FDA data (Drugs@FDA), reproduced as published. SPEQ is not affiliated with the FDA, adds no interpretation to the record, and nothing here is medical, legal, or regulatory advice.
APPLICATION
ANDA221049
TYPE
ANDA
ORIGINAL APPROVAL
2026-10-14
LATEST ACTION
2026-10-14
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
LUBIPROSTONEPrescription
LUBIPROSTONE 24MCG · CAPSULE · ORAL
LUBIPROSTONEPrescription
LUBIPROSTONE 8MCG · CAPSULE · ORAL
Approval history
2026-10-14UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →