ALOSETRON HYDROCHLORIDE | A206113 | PH HEALTH LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Prometheus Laboratories Inc. v. Par Pharmaceutical Companies Inc. et al 1 patentANDA 206113alosetron hydrochloride | D. Del. | 2014-08-06 | Terminated 2015-11-17 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Prometheus Laboratories Inc. - Citizen Petition FDA-2013-P-0572 · 3 docket documents Prometheus Laboratories Inc. filed this citizen petition on May 10, 2013, requesting that the FDA establish notice-and-comment rulemaking to create standards and processes for single shared Risk Evaluation and Mitigation Strategies (REMS) for Lotronex (alosetron hydrochloride), and that Prometheus r | 505(q) | 2013-05-28 | Partially Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.