TRAZODONE HYDROCHLORIDE | A071196 | APOTEX INC
| 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 |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.5274
per ea
Lowest NADAC/Unit
$0.0495
per ea
Brand NDCs
0
Generic NDCs
4
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00555071102TRAZODONE 300 MG TABLET | $0.5274 | EA | Generic | — | 2026-06-17 |
| 60505265901TRAZODONE 300 MG TABLET | $0.5274 | EA | Generic | — | 2026-06-17 |
| 60505265501TRAZODONE 150 MG TABLET | $0.0900 | EA | Generic | — | 2026-06-17 |
| 60505265401TRAZODONE 100 MG TABLET | $0.0495 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.