METHIMAZOLE | N007517 | KING PHARMACEUTICALS INC
| 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 |
Suitability Petition from Hyman, Phelps & McNamara, P.C. 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 | Suitability | 2024-10-23 | Open | Hyman |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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