BORTEZOMIB | N205004 | FRESENIUS KABI USA LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2013-03-22 | Terminated 2014-04-14 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Millennium Pharmaceuticals, Inc. FDA-2017-P-3672 Millennium Pharmaceuticals, Inc. filed this Section 505(q) citizen petition on June 8, 2017, requesting that the FDA refrain from approving any ANDA or 505(b)(2) bortezomib product for multiple myeloma or mantle cell lymphoma with labeling that omits protected safety and efficacy information, identi | 505(q) | 2017-06-13 | Denied | Millennium Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 8962572 | Nov 3, 2032 | — | — | Yes | — | — |