APPLICATION
ANDA209450
TYPE
ANDA
ORIGINAL APPROVAL
2021-11-30
LATEST ACTION
2022-05-05
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
LUBIPROSTONEPrescription
LUBIPROSTONE 8MCG · CAPSULE · ORAL
LUBIPROSTONEPrescription
LUBIPROSTONE 24MCG · CAPSULE · ORAL
Approval history
2022-05-05Manufacturing (CMC) · Supplement 2 · standardAP
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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