PRIMIDONE

FDA-2022-P-3118 · 6 docket documents

Hyman, Phelps & McNamara P.C. filed this citizen petition pursuant to sections 505(j) and 505(w) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine whether MYSOLINE (primidone) Suspension, 250 mg/5 mL, approved under NDA 010401 and held by Nuro Pharma LLC, was withdrawn fo

FDA-2009-P-0482 · 8 docket documents

Lachman Consultant Services, Inc. filed this citizen petition on behalf of a client under Section 505(j)(2)(C) requesting that the FDA declare Primidone Tablets USP in 100 mg and 125 mg strengths suitable for consideration in an abbreviated new drug application, with the reference-listed drug being

FDA-2009-P-0481 · 7 docket documents

Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA declare Primidone Orally Disintegrating Tablets in strengths of 50 mg, 100 mg, 125 mg, and 250 mg suitable for consideration in an ANDA, with the reference-listed drug being Mysoline (primidone) Table

FDA-2009-P-0477 · 7 docket documents

Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA declare Primidone Capsules in 50 mg, 100 mg, 125 mg, and 250 mg strengths suitable for consideration in an abbreviated new drug application under Section 505(j)(2)(C), with the reference-listed drug b

FDA-2008-P-0557 · 4 docket documents

Schiff & Company, representing JFAS LLC, filed this citizen petition requesting that the FDA determine whether Mysoline (Primidone) Oral Suspension 250 mg/5 mL, NDA 010401, was voluntarily withdrawn for reasons unrelated to safety and effectiveness, pursuant to 21 CFR 314.161(a)(1), to establish whe