CARFILZOMIB | A209422 | DR REDDYS LABORATORIES LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Onyx Therapeutics, Inc. v. Dr. Reddys Laboratories, Inc et al. 8 patentsANDA 209422carfilzomib | D. Del. | 2017-12-18 | Terminated 2019-05-16 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 2 Proposed Package Labeling for Carfilzomib re Suitability Petitio... FDA-2015-P-1590 Qilu Pharmaceutical Co., Ltd. filed a petition requesting approval to market a carfilzomib formulation in the United States, submitting proposed package labeling as part of their suitability petition to demonstrate compliance with FDA requirements for the drug product. | Suitability | 2015-05-12 | Open | Qilu Pharmaceutical Co. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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