METHIMAZOLE | A040320 | KING PHARMACEUTICALS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Ceva Animal Health, LLC FDA-2023-P-5171 · 7 docket documents Ceva Santé Animale submitted this petition under Section 512(n)(3) of the Federal Food, Drug and Cosmetic Act on November 10, 2023, requesting permission to file an Abbreviated New Animal Drug Application (ANADA) for a generic methimazole oral solution for treating feline hyperthyroidism, which diff | Suitability | 2023-11-21 | Granted | Ceva Animal Health, LLC |
Suitability Petition from Mizner Bioscience LLC FDA-2023-P-0075 · 3 docket documents Mizner Bioscience LLC filed 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 Methimazole Oral Solution for cats, which would differ from the reference product FELIMAZOLE (me | Suitability | 2023-01-06 | Granted | Mizner Bioscience LLC |
Suitability Petition from Felix Pharmaceuticals Pvt Ltd FDA-2021-P-1174 · 5 docket documents Felix Pharmaceuticals Pvt. Ltd. submitted this 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 for a generic oral solution formulation of Methimazole that differs from the pioneer product | Suitability | 2021-10-28 | Granted | Felix Pharmaceuticals Pvt Ltd |
Citizen Petition from Norbrook Inc. FDA-2018-P-2985 · 7 docket documents Norbrook Laboratories Limited filed this suitability petition under section 512(n)(3) of the Federal Food, Drug, and Cosmetic Act requesting permission to submit an Abbreviated New Animal Drug Application (ANADA) for Methimazole 5 mg/mL Oral Solution as a generic version of the pioneer product FELIM | Other | 2018-08-01 | Granted | Norbrook Inc. |
Citizen Petition from e5 Pharma LLC FDA-2016-P-1169 · 15 docket documents e5 Pharma, LLC filed this 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 for Methimazole Rapidly-Disintegrating Tablets, a generic version of the pioneer product FELIMAZOLE (methimazole) | Other | 2016-04-19 | Denied | e5 Pharma LLC |
Suitability Petition Approval Response Letter from FDA CVM to e5 Pharma LLC FDA-2014-P-1802 · 5 docket documents e5 Pharma LLC filed a suitability petition (FDA-2014-P-1802) requesting approval to submit an abbreviated new animal drug application (ANADA) for a methimazole oral solution for cats with hyperthyroidism, a change in dosage form from the reference listed new animal drug FELIMAZOLE (methimazole) Coat | Suitability | 2015-01-14 | Granted | — |
Citizen Petition From E5 Pharma LLC FDA-2014-P-0794 · 5 docket documents E5 Pharma, LLC submitted this 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 a generic methimazole chewable tablet for cats, which would differ from the pioneer product FELI | Other | 2014-06-16 | Granted | E5 Pharma LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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