ACETYLCYSTEINE | N021539 | CUMBERLAND PHARMACEUTICALS INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2013-07-12 | Terminated 2017-04-11 | — | |
| D. Del. | 2012-05-17 | Terminated 2013-11-01 | — | |
Cumberland Pharmaceuticals Inc. v. Mylan Institutional LLC et al 1 patentANDA 203624N-acetylcysteine (acetylcysteine) | N.D. Ill. | 2012-05-17 | Terminated 2015-11-17 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Cumberland Pharmaceuticals Inc. FDA-2025-P-6019 Cumberland Pharmaceuticals Inc. filed this citizen petition under section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA decline to approve any ANDA or section 505(b)(2) application for acetylcysteine (ACETADOTE) products with labeling that omits information about the two | 505(q) | 2025-11-12 | Open | Cumberland Pharmaceuticals Inc. |
Citizen Petition from Frontage Laboratories, Inc. FDA-2016-P-1085 Beijing Health Life Pharm-Tech Co., Ltd., filing through U.S. agent Frontage Laboratories, Inc., submitted a suitability petition under 505(j)(2)(c) requesting authorization to submit an ANDA for acetylcysteine injection in 2g/10mL and 4g/20mL strengths using ACETADOTE (NDA #021539, 6g/30mL) as the | Other | 2016-04-08 | Denied | Frontage Laboratories |
Source: Regulations.gov. FDA citizen petitions matched by application number.