FAMOTIDINE; IBUPROFEN | N022519 | HORIZON MEDICINES LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Horizon Pharma Inc. et al v. Par Pharmaceutical Companies, Inc. et al 2 patentsANDA 203658Famotidine and Ibuprofen | D. Del. | 2013-01-17 | Terminated 2013-10-17 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Aurobindo Pharma USA, Inc., FDA-2024-P-0827 Aurobindo Pharma USA, Inc. filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine whether DUEXIS (Ibuprofen and Famotidine) Tablets 800 mg and 26.6 mg, NDA 022519, originally approved to Horizon Medicines LLC, was voluntarily wi | 505(q) | 2024-02-15 | Granted | Aurobindo Pharma USA |
Source: Regulations.gov. FDA citizen petitions matched by application number.