PALONOSETRON HYDROCHLORIDE | A206396 | CIPLA LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Hogan Lovells US LLP (Helsinn) FDA-2015-P-1721 · 7 docket documents 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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