PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | N050684 | WYETH PHARMACEUTICALS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen petition from Qilu Pharmaceutical Co., Ltd FDA-2020-P-1356 Qilu Pharma, Inc., the US agent for Qilu Pharmaceutical Co., Ltd., filed this petition on May 7, 2020, requesting that the FDA designate a second reference listed drug (RLD) for Piperacillin and Tazobactam for Injection (EQ 36 GM BASE/VIAL; EQ 4.5 GM BASE/VIAL) because the current RLD, Zosyn, is in | Other | 2020-05-08 | Withdrawn | Qilu Pharmaceutical Co., Ltd |
Sandoz Inc. - Citizen Petition FDA-2005-P-0003 Sandoz Inc. petitioned the FDA under section 505(j)(2)(c) to determine that the discontinued formulation of Wyeth's Zosyn (piperacillin and tazobactam for injection) referenced in NDA 50-684 was not discontinued for safety or efficacy reasons, and to accept Sandoz's ANDAs for piperacillin and tazoba | Other | 2009-09-16 | Granted | — |
Citizen Petition from Orchid Healthcare FDA-2006-P-0391 Orchid Healthcare filed a citizen petition pursuant to Section 505(j)(2)(c) requesting that the FDA determine that Wyeth Pharmaceuticals discontinued its previously-approved formulation of Zosyn (piperacillin and tazobactam for injection) in the 40.5 gram pharmacy bulk vial for reasons unrelated to | 505(q) | 2008-12-17 | Granted | Orchid Healthcare |
Citizen Petition from Wyeth Pharmaceuticals FDA-2006-P-0019 Wyeth Pharmaceuticals submitted a citizen petition on April 25, 2006, under section 505 of the Federal Food, Drug, and Cosmetic Act requesting that FDA approval of any ANDA or 505(b)(2) application for generic piperacillin and tazobactam for injection (Zosyn) be contingent upon the generic product c | 505(q) | 2008-05-20 | Partially Denied | Wyeth Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.