DESYREL

FDA-2026-P-6083

Hyman, Phelps & McNamara, P.C. filed a suitability petition requesting that the FDA determine whether a particular drug substance or excipient is suitable for use in pharmaceutical products. The petition seeks FDA guidance on regulatory pathways and manufacturing standards applicable to the proposed

FDA-2026-P-4853

Graviti Pharmaceuticals Private Limited filed this suitability petition requesting FDA approval under section 505(j)(2)(C) of the FDC Act to permit submission of an ANDA for Trazodone Hydrochloride Tablets, USP 200 mg strength, a new dosage strength that differs from the reference listed drug DESYRE

FDA-2023-P-4394

Drug Device Consulting LLC filed a citizen petition requesting FDA approval of a draft label for Trazodone Hydrochloride Tablets in 25 mg and 75 mg strengths, seeking a determination of suitability for these formulations under the regulatory framework for abbreviated new drug applications or generic

FDA-2023-P-4394

Drug Device Consulting LLC filed this suitability petition requesting that the FDA declare Trazodone Hydrochloride Tablets in 25 mg and 75 mg strengths suitable for submission as an ANDA, with Pragma Pharmaceuticals' Desyrel tablets as the reference listed drug. The petitioner argues these intermedi

FDA-2023-P-4394

Drug Device Consulting LLC filed a citizen petition regarding the suitability of trazodone hydrochloride tablets as a reference listed drug (RLD). The petition appears to address regulatory standards for generic drug approvals under the ANDA process, with the attachment providing labeling informatio

FDA-2021-P-0137

The law firm Hyman, Phelps & McNamara, P.C., on behalf of an unnamed client, submitted a suitability petition 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 Trazodone Hydrochloride Tablets, 25 mg, suitable for submission

FDA-2014-P-0646

Kamat Pharmatech LLC filed this suitability petition pursuant to 21 CFR §314.93 and section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act, requesting FDA approval to submit an ANDA for Trazodone Hydrochloride Oral Solution at 10 mg/mL, a change in dosage form from the reference listed drug

FDA-2014-P-0646

Kamat Pharmatech filed this suitability petition on June 13, 2014, pursuant to 21 CFR section 314.93 and section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act, requesting FDA approval to submit an abbreviated new drug application for Trazodone Hydrochloride Oral Solution in the strength of