MELOXICAM | N207233 | ICEUTICA OPERATIONS LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2018-04-20 | Terminated 2020-01-22 | — | |
| D. Del. | 2018-04-06 | Terminated 2018-05-09 | — | |
| D. Del. | 2017-10-31 | Terminated 2018-06-08 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Aurora Pharmaceutical, Inc. FDA-2024-P-4126 · 6 docket documents Aurora Pharmaceutical, Inc. filed a suitability petition in August 2024 requesting FDA permission to submit an abbreviated new animal drug application (ANADA) for a generic meloxicam oral solution at 3 mg/mL strength for dogs over 10 lbs., which differs from the reference listed new animal drug Meta | Suitability | 2024-08-29 | Open | Aurora Pharmaceutical, Inc. |
Suitability Petition from Aurora Pharmaceutical, Inc. FDA-2024-P-1716 · 5 docket documents Aurora Pharmaceutical, Inc. filed this suitability petition in April 2024 requesting FDA permission under Section 512(n)(3) of the Federal Food, Drug and Cosmetic Act to submit an abbreviated new animal drug application (ANADA) for meloxicam oral solution 5 mg/mL for dogs weighing more than 10 lbs., | Suitability | 2024-04-05 | Denied | Aurora Pharmaceutical, Inc. |
Suitability Petition from Aurora Pharmaceutical, Inc. FDA-2022-P-2795 · 6 docket documents Aurora Pharmaceutical, Inc. filed a suitability petition in November 2022 requesting FDA permission to submit an abbreviated new animal drug application for a generic meloxicam oral solution in 1.5 mg/mL and 0.5 mg/mL strengths for dogs, which differs from the reference listed new animal drug Metaca | Suitability | 2022-11-07 | Granted | Aurora Pharmaceutical, Inc. |
Citizen Petition from Camargo Pharmaceutical Services FDA-2005-P-0329 · 10 docket documents Camargo Pharmaceutical Services filed this citizen petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA permit the filing of an ANDA for Meloxicam Orally Disintegrating Tablets at 7.5 mg and 15 mg strengths, using Mobic (Meloxicam Tablets) as t | Other | 2015-09-30 | Denied | Camargo Pharmaceutical Services |
Ceva Animal Health, LLC (CEVA Santé Animale) - Citizen Petition FDA-2011-P-0078 · 4 docket documents Ceva Animal Health, LLC filed this suitability petition on February 2, 2011, pursuant to 21 CFR §10.30 and Federal Food, Drug, and Cosmetic Act Section 512(n)(3), requesting FDA approval to submit an abbreviated new animal drug application (ANADA) for meloxicam oral suspension for dogs. The proposed | Other | 2011-02-08 | Denied | — |
Citizen Petition from Norbrook Laboratories, Ltd FDA-2007-P-0497 · 4 docket documents Norbrook Laboratories, Ltd submitted a Suitability Petition under section 512(n)(3) of the Federal Food, Drug, and Cosmetic Act requesting permission to file an Abbreviated New Animal Drug Application (ANADA) for meloxicam in a chewable tablet dosage form for dogs, which differs from the pioneer pro | Other | 2008-05-19 | Denied | Norbrook Laboratories, Ltd |
Source: Regulations.gov. FDA citizen petitions matched by application number.