CORTEF

FDA-2026-P-3242 · 6 docket documents

Appco Pharma LLC filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting FDA approval to submit an Abbreviated New Drug Application for Hydrocortisone Tablets USP in 2.5 mg and 7.5 mg strengths, which differ from the currently approved Referen

FDA-2026-P-1308 · 7 docket documents

The law firm Hyman, Phelps & McNamara, P.C., filed this suitability petition on behalf of a client seeking FDA approval under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act to declare that Hydrocortisone Tablets in 2.5 mg, 7.5 mg, and 15 mg strengths are suitable for submission in a

FDA-2025-P-1070 · 8 docket documents

Epstein Becker & Green, P.C., filed this suitability petition under Federal Food, Drug, and Cosmetic Act Section 505(j)(2)(C) requesting that the FDA determine hydrocortisone topical gel 2.5% suitable for submission as an Abbreviated New Drug Application, with the listed drug being Texacort (hydroco

FDA-2025-P-0441 · 4 docket documents

Epstein Becker & Green, P.C., filed this citizen petition requesting that the FDA determine whether Nutracort (topical hydrocortisone gel 1%), approved under NDA N84698 and held by Healthpoint Ltd., was voluntarily withdrawn from the market for reasons of safety or effectiveness, as required under S

FDA-2020-P-1074 · 8 docket documents

Akorn Animal Health Inc. filed this petition under section 512(n)(3) of the Federal Food, Drug, and Cosmetic Act requesting FDA permission to pursue approval of an Abbreviated New Animal Drug Application for Neomycin and Polymixin B Sulfates, Bacitracin Zinc, and Hydrocortisone Ophthalmic Ointment,

FDA-2015-P-1090 · 7 docket documents

Baker Hostetler LLP, on behalf of an unnamed client, filed this petition under 21 U.S.C. § 505 requesting that the FDA declare New Drug Application 17-351 for Cortifoam (hydrocortisone acetate) was not validly approved and should be withdrawn from the market because the application never satisfied s

FDA-2007-P-0053 · 3 docket documents

West-Ward Pharmaceutical Corp. filed this petition under 21 CFR 10.25(a) and 10.30 to request that the FDA determine whether Hydrocortisone Tablets USP, 10 mg (CORTEF, NDA 008697), which was voluntarily withdrawn from distribution by Pharmacia and Upjohn, was shortened for safety or effectiveness re