PALONOSETRON HYDROCHLORIDE | A206396 | CIPLA LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Hogan Lovells US LLP (Helsinn) FDA-2015-P-1721 Helsinn Healthcare SA, represented by Hogan Lovells US LLP, filed this citizen petition under Section 505(q) of the Food, Drug, and Cosmetic Act regarding Cipla Limited's ANDA 206396 for a generic version of ALOXI (palonosetron hydrochloride) Injection. Helsinn requests that FDA require Cipla to sub | 505(q) | 2015-05-18 | Denied | Hogan Lovells US LLP (Helsinn) |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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