LUBIPROSTONE | A201442 | PH HEALTH LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition From Sucampo Pharma Americas, LLC FDA-2014-P-0144 · 3 docket documents Sucampo Pharma Americas, LLC filed this citizen petition under sections 505(j) and 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that FDA revise its draft bioequivalence criteria for lubiprostone capsules and apply the revised criteria to any abbreviated new drug application listing | 505(q) | 2014-01-31 | Denied | Sucampo Pharma Americas, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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