LEVOTHYROXINE SODIUM | N214253 | HIKMA PHARMACEUTICALS USA INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Colo. | 2020-10-30 | Terminated 2021-02-19 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Fresenius Kabi USA, LLC FDA-2020-P-2133 · 4 docket documents Fresenius Kabi USA, LLC filed this citizen petition pursuant to Section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA refuse to file or accept any ANDA or 505(b)(2) application for levothyroxine sodium intravenous solution products unless they reference Fresenius Kabi's | 505(q) | 2020-10-28 | Denied | Fresenius Kabi USA, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 11154498 | Jul 20, 2036 | — | — | Yes | — | — |