TOLVAPTAN | N022275 | OTSUKA PHARMACEUTICAL CO LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2014-06-20 | Terminated 2015-09-23 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Otsuka Pharmaceutical Development & Commercialization, ... FDA-2019-P-4002 Otsuka Pharmaceutical Co., Ltd. filed this citizen petition under FDCA sections 505(j) and 505(q) requesting that FDA determine SAMSCA (tolvaptan) 60 mg tablets should be deemed withdrawn for safety reasons and refuse to approve any pending ANDAs with SAMSCA 60 mg as the reference listed drug, or su | 505(q) | 2019-08-26 | Denied | Otsuka Pharmaceutical Development & Commercialization |
Source: Regulations.gov. FDA citizen petitions matched by application number.