PALONOSETRON HYDROCHLORIDE | N203050 | AVYXA HOLDINGS LLC
| 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 1 patentpalonosetron hydrochloride | D.N.J. | 2012-05-11 | Terminated 2017-03-06 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Lachman Consultant Services, Inc. - Citizen Petition FDA-2012-P-0458 · 4 docket documents Lachman Consultant Services, Inc. filed this petition requesting that the FDA determine whether Aloxi (palonosetron hydrochloride) Capsules, 0.5 mg, approved under NDA 22-233, was voluntarily withdrawn or withheld from sale for safety or effectiveness reasons pursuant to 21 CFR 314.161 and 314.162, | 505(q) | 2012-05-10 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.