ZOLEDRONIC ACID | N021817 | SANDOZ INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C FDA-2024-P-1483 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 | Open | Hyman |
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 | — | — |