ZOLEDRONIC ACID | N021223 | NOVARTIS PHARMACEUTICALS CORP
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D.N.J. | 2013-11-08 | Terminated 2014-01-07 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Novartis Pharmaceuticals Corporation - Citizen Petition FDA-2013-P-0247 · 6 docket documents Novartis Pharmaceuticals Corporation filed this citizen petition on March 1, 2013, requesting that the Commissioner not approve any abbreviated new drug application (ANDA) for a zoledronic acid injectable IV product based on omitting protected information from Reclast labeling, arguing that such car | 505(q) | 2013-03-14 | Denied | — |
Sun Pharmaceuticals, Ltd. - Citizen Petition FDA-2007-P-0250 · 5 docket documents Sun Pharmaceuticals Limited filed this citizen petition in September 2007 requesting that the FDA determine whether the lyophilized formulation of Zometa (zoledronic acid for injection) containing 4 mg per vial was withdrawn for safety or effectiveness reasons under 21 CFR 314.161, and seeking appro | Other | 2008-05-06 | Partially Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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