FDA Orange Book · active-ingredient family
Trazodone hydrochloride
Trazodone hydrochloride is approved as 3 brand and 33 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:RALDESY · NDA 218637
3
Brand (NDA)
33
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution, tablet, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| RALDESYRLD | KAMAT | NDA 218637 | — | Nov 26, 2024 | |
| OLEPTRORLD×2 | ANGELINI PHARMA | NDA 022411 | — | Feb 02, 2010 | |
| DESYRELRLD×4 | PRAGMA | NDA 018207 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (33)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TRAZODONE HYDROCHLORIDE×4 | GRAVITI PHARMS | ANDA 217740 | AB | Aug 27, 2024 | |
| TRAZODONE HYDROCHLORIDE×4 | GRANULES | ANDA 218988 | AB | Aug 08, 2024 | |
| TRAZODONE HYDROCHLORIDE×4 | CROSSMEDIKA SA | ANDA 211116 | AB | May 20, 2024 | |
| TRAZODONE HYDROCHLORIDE×4 | AUROBINDO PHARMA | ANDA 204852 | AB | Feb 05, 2020 | |
| TRAZODONE HYDROCHLORIDE×4 | ZYDUS PHARMS | ANDA 205253 | AB | Oct 10, 2017 | |
| TRAZODONE HYDROCHLORIDE×4 | ACCORD HLTHCARE | ANDA 206923 | AB | Sep 08, 2017 | |
| TRAZODONE HYDROCHLORIDE×4 | TORRENT | ANDA 202180 | AB | Nov 27, 2013 | |
| TRAZODONE HYDROCHLORIDE×4 | PHARMOBEDIENT | ANDA 090514 | — | Jun 02, 2009 | |
| TRAZODONE HYDROCHLORIDE | TEVA | ANDA 074357 | — | Apr 30, 1997 | |
| TRAZODONE HYDROCHLORIDE×3 | SUN PHARM INDUSTRIES | ANDA 073137 | AB | Mar 24, 1993 | |
| TRAZODONE HYDROCHLORIDE | NATCO | ANDA 071405 | — | Feb 27, 1991 | |
| TRAZODONE HYDROCHLORIDE | NATCO | ANDA 071406 | — | Feb 27, 1991 | |
| TRAZODONE HYDROCHLORIDE | AIPING PHARM INC | ANDA 072483 | — | Apr 30, 1990 | |
| TRAZODONE HYDROCHLORIDE | RISING | ANDA 072484 | — | Apr 30, 1990 | |
| TRAZODONE HYDROCHLORIDE | OXFORD PHARMS | ANDA 072192 | AB | Feb 02, 1989 | |
| TRAZODONE HYDROCHLORIDE | OXFORD PHARMS | ANDA 072193 | AB | Feb 02, 1989 | |
| TRAZODONE HYDROCHLORIDE | ALVOGEN | ANDA 071636 | — | Apr 18, 1988 | |
| TRAZODONE HYDROCHLORIDE | ALVOGEN | ANDA 071514 | — | Apr 18, 1988 | |
| TRAZODONE HYDROCHLORIDE | PLIVA | ANDA 071525 | AB | Mar 09, 1988 | |
| TRAZODONE HYDROCHLORIDE | TEVA PHARMS USA | ANDA 071523 | AB | Dec 11, 1987 | |
| TRAZODONE HYDROCHLORIDE | TEVA PHARMS USA | ANDA 071524 | AB | Dec 11, 1987 | |
| TRAZODONE HYDROCHLORIDE | USL PHARMA | ANDA 070491 | — | Apr 29, 1987 | |
| TRAZODONE HYDROCHLORIDE | USL PHARMA | ANDA 070492 | — | Apr 29, 1987 | |
| TRAZODONE HYDROCHLORIDE | APOTEX | ANDA 071258 | AB | Mar 25, 1987 | |
| TRAZODONE HYDROCHLORIDE×3 | APOTEX INC | ANDA 071196 | AB | Mar 25, 1987 | |
| TRAZODONE HYDROCHLORIDE | QUANTUM PHARMICS | ANDA 070921 | — | Dec 01, 1986 | |
| TRIALODINE | QUANTUM PHARMICS | ANDA 070942 | — | Dec 01, 1986 | |
| TRAZODONE HYDROCHLORIDE | WATSON LABS | ANDA 071112 | — | Nov 17, 1986 | |
| TRAZODONE HYDROCHLORIDE | WATSON LABS | ANDA 071113 | — | Nov 17, 1986 | |
| TRAZODONE HYDROCHLORIDE | AM THERAP | ANDA 071139 | — | Oct 29, 1986 | |
| TRAZODONE HYDROCHLORIDE | AM THERAP | ANDA 071140 | — | Oct 29, 1986 | |
| TRAZODONE HYDROCHLORIDE | WATSON LABS | ANDA 070857 | — | Oct 10, 1986 | |
| TRAZODONE HYDROCHLORIDE | WATSON LABS | ANDA 070858 | — | Oct 10, 1986 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7829120 | Mar 27, 2027 | in 9 mo | ProductU-796 |
| 8133893 | Mar 13, 2029 | in 2 yr 9 mo | SubstanceProduct |
Trazodone hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
