ZOLEDRONIC ACID | N021817 | SANDOZ INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C FDA-2024-P-1483 · 7 docket documents Hyman, Phelps & McNamara, P.C., on behalf of a client, submitted this Suitability Petition pursuant to FD&C Act Section 505(q) requesting that the FDA Commissioner declare Sugammadex Injection (100 mg/mL in a 2 mL single-dose prefilled syringe) suitable for submission in an Abbreviated New Drug Appl | Suitability | 2024-03-28 | Granted | Hyman, Phelps & McNamara, P.C |
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determine whether the lyophilized formulation of Zometa (zoledronic acid for injection) containing 4 mg per vial was withdrawn for safety or effectiveness reasons under 21 CFR 314.161, and seeking appro | Other | 2008-05-06 | Partially Denied | — |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.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 7932241 | Feb 5, 2028PED: Aug 5, 2028 | PED | — | Yes | — | — |