PIPERACILLIN SODIUM | A065157 | ISTITUTO BIOCHIMICO ITALIANO SPA
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Zydus Pharmaceuticals USA Inc. FDA-2014-P-1603 · 6 docket documents Zydus Pharmaceuticals USA Inc. filed a citizen petition requesting that the FDA take enforcement action against manufacturers of unapproved piperacillin and tazobactam intravenous products and issue guidance to prevent the continued marketing of such products without proper NDA or ANDA approval, cit | Other | 2014-10-14 | Withdrawn | Zydus Pharmaceuticals USA Inc. |
Samson Medical Technologies, L.L.C. - Citizen Petition FDA-2011-P-0031 · 4 docket documents Samson Medical Technologies, LLC filed this citizen petition requesting FDA suitability determination for an ANDA involving piperacillin and tazobactam for injection in 337.5 and 405 gram pharmacy bulk packages. The petition seeks clarification on regulatory pathway requirements for this combination | Other | 2011-02-07 | Granted | — |
Sandoz Inc. - Citizen Petition FDA-2005-P-0003 · 9 docket documents 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 · 11 docket documents 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 |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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