PALONOSETRON HYDROCHLORIDE | A201533 | DR REDDYS LABORATORIES LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
HELSINN HEALTHCARE S.A. et al v. DR. REDDY'S LABORATORIES, LTD. et al 1 patentANDA 201533palonosetron hydrochloride | D.N.J. | 2014-07-07 | Terminated 2019-12-06 | — |
HELSINN HEALTHCARE S.A. et al v. DR. REDDY'S LABORATORIES, LTD. et al 2 patentsANDA 201533, 202521, 090713palonosetron hydrochloride | D.N.J. | 2011-07-08 | Terminated 2015-11-16 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Exela Pharma Sciences FDA-2018-P-1197 Exela Pharma Sciences filed this petition requesting that the FDA assign a therapeutic equivalence code of "AP" in the Orange Book for Exela's Palonosetron Hydrochloride Injection 0.125 mg/mL (2 mL vial) approved under NDA 207963, claiming the product is pharmaceutically and therapeutically equivale | Other | 2018-03-20 | Denied | Exela Pharma Sciences |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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