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for Injection (EQ 36 GM BASE/VIAL; EQ 4.5 GM BASE/VIAL) because the current RLD, Zosyn, is in | Other | 2020-05-08 | Withdrawn | Qilu Pharmaceutical Co. |
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.
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