METHIMAZOLE | A040320 | KING PHARMACEUTICALS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2025-P-4047 The law firm Hyman, Phelps & McNamara, P.C., on behalf of an unnamed client, filed this suitability petition pursuant to Section 505(j)(2)(C) of the FDC Act requesting that the FDA declare Methimazole Oral Solution, 1 mg/mL, suitable for submission as an ANDA, with the reference listed drug being Pf | Suitability | 2025-09-19 | Open | Hyman |
Citizen Petition from e5 Pharma LLC FDA-2016-P-1169 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 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 | Open | — |
Citizen Petition From E5 Pharma LLC FDA-2014-P-0794 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 | Open | E5 Pharma LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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