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 · 21 docket documents 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 Dsquare LLC FDA-2024-P-2955 · 6 docket documents Dsquare LLC filed a citizen petition under 21 CFR 10.30 requesting that the FDA require sodium-containing N-Acetylcysteine products marketed for acetaminophen intoxication treatment include warnings about high sodium content in patient information and a Black Box Warning for salt-sensitive individua | 505(q) | 2024-06-21 | Open | Dsquare LLC |
Citizen Petition from Foley & Lardner LLP FDA-2020-P-1236 · 4 docket documents Foley & Lardner LLP, on behalf of Fresenius Kabi USA LLC, filed a citizen petition under 21 CFR § 10.30 requesting that the FDA designate Acetylcysteine Injection 6gm/30mL (ANDA 200644) as a reference listed drug in the Orange Book to serve as the basis for filing future ANDAs. The petitioner argues | Other | 2020-04-01 | Denied | Foley & Lardner LLP |
Citizen Petition from Frontage Laboratories, Inc. FDA-2016-P-1085 · 4 docket documents 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 | Granted | Frontage Laboratories, Inc. |
Cumberland Pharmaceutical Inc. (Covington & Burling) - Citizen Petition FDA-2012-P-0507 · 5 docket documents Cumberland Pharmaceuticals Inc. submitted a citizen petition under section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA not approve any ANDA for acetylcysteine injection that contains edetate disodium (EDTA) as a component, since Cumberland's NDA-approved ACETADOTE bran | 505(q) | 2012-05-23 | Partially Denied | — |
Leydig, Voit & Mayer, LTD - Citizen Petition FDA-2011-P-0339 · 5 docket documents The law firm Leydig, Voit & Mayer filed this citizen petition on behalf of a client requesting that the FDA determine the discontinued original formulation of Acetadote (acetylcysteine) Injection NDA 21-539, which contained disodium edetate, was not withdrawn for safety or efficacy reasons, thereby | 505(q) | 2011-05-17 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.