TRAZODONE HYDROCHLORIDE | N018207 | PRAGMA PHARMACEUTICALS LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2021-03-26 | Terminated 2022-01-26 | — | |
Aziende Chimiche Riunite Angelini Francesco ACRAFSpA v. Aurobindo Pharma USA Inc. 1 patentANDA 204852trazodone hydrochloride | D. Del. | 2019-11-25 | Terminated 2021-09-08 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-6083 · 7 docket documents Hyman, Phelps & McNamara, P.C., filing on behalf of a client, submitted this 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 the FDA declare Trazodone Hydrochloride Tablets, 12.5 mg, suitable for submission in an | Suitability | 2026-05-28 | Open | Hyman, Phelps & McNamara, P.C. |
Suitability Petition from Graviti Pharmaceuticals Private Limited FDA-2026-P-4853 · 8 docket documents Graviti Pharmaceuticals Private Limited filed this suitability petition pursuant to section 505(j)(2)(C) of the FDC Act requesting FDA approval to submit an Abbreviated New Drug Application for Trazodone Hydrochloride Tablets, USP 200 mg, a new strength that differs from the reference listed drug DE | Suitability | 2026-05-05 | Open | Graviti Pharmaceuticals Private Limited |
Suitability Petition from Drug Device Consulting LLC FDA-2023-P-4394 · 7 docket documents 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 | Suitability | 2023-10-10 | Granted | Drug Device Consulting LLC |
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2021-P-0137 · 6 docket documents 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 | Suitability | 2021-02-02 | Granted | Hyman, Phelps & McNamara, P.C. |
Citizen Petition from Kamat Pharmatech FDA-2014-P-0646 · 12 docket documents 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 | Other | 2014-05-22 | Withdrawn | Kamat Pharmatech |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 8133893 | Mar 13, 2029 | — | Yes | Yes | — | — |