TAPAZOLE

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

FDA-2024-P-4936

The law firm Hyman, Phelps & McNamara filed this suitability petition on behalf of a client pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93 requesting that FDA declare Methimazole Tablets in 2.5 mg and 7.5 mg strengths suitable for submission as an

FDA-2023-P-5171

Ceva Animal Health, LLC filed a suitability petition requesting permission to submit an abbreviated new animal drug application (ANADA) for a generic methimazole oral solution (10 mg/mL) that differs in dosage form and strength from the reference listed new animal drug Felimazole Coated Tablets (2.5

FDA-2023-P-5171

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

FDA-2023-P-0075

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

FDA-2021-P-1174

Felix Pharmaceuticals Pvt. Ltd. filed suitability petition FDA-2021-P-1174 requesting permission to submit an abbreviated new animal drug application for a generic methimazole oral solution (5 mg/mL) that differs in dosage form from the reference listed new animal drug Felimazole Coated Tablets. The

FDA-2021-P-1174

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

FDA-2018-P-2985

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

FDA-2016-P-1169

e5 Pharma, LLC filed this petition for reconsideration of the Center for Veterinary Medicine's June 10, 2016 denial of their suitability petition regarding FELIMAZOLE (methimazole). The company requests permission to file an Abbreviated New Animal Drug Application (ANADA) for a methimazole rapidly-d

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)

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

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