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. 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 | 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 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 | 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 | GrantedNo FDA response document on docket | Drug Device Consulting LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.5292
per ea
Lowest NADAC/Unit
$0.0506
per ea
Brand NDCs
0
Generic NDCs
4
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00555071102TRAZODONE 300 MG TABLET | $0.5292 | EA | Generic | — | 2026-08-19 |
| 60505265901TRAZODONE 300 MG TABLET | $0.5292 | EA | Generic | — | 2026-08-19 |
| 60505265501TRAZODONE 150 MG TABLET | $0.0882 | EA | Generic | — | 2026-08-19 |
| 60505265401TRAZODONE 100 MG TABLET | $0.0506 | EA | Generic | — | 2026-08-19 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.