Trazodone Extended Release Oral Tablet
- Brand(s)
- Oleptro
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Oldest Current Product
- 2010-02-02
- License(s)
- NDA
- RxNORM
- EXTENDED RELEASE ORAL TABLET\TRAZODONE
- FDAOB
- ORAL\TABLET, EXTENDED RELEASE\TRAZODONE HYDROCHLORIDE
- SPL Active
- ORAL\TABLET, EXTENDED RELEASE\TRAZODONE HYDROCHLORIDE
- SPL Moiety
- ORAL\TABLET, EXTENDED RELEASE\TRAZODONE
product(s) by strength(s)
invalid application product(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|
| 1 | 435950080 | Oleptro | NDA | Angelini Pharma Inc. | 2010-02-02 | TRAZODONE HYDROCHLORIDE | ORAL | TABLET, EXTENDED RELEASE | NDA022411 | 88c45123-f475-4dd0-bbac-c261868924ef |
invalid application product(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|
| 1 | 435950081 | Oleptro | NDA | Angelini Pharma Inc. | 2010-02-02 | TRAZODONE HYDROCHLORIDE | ORAL | TABLET, EXTENDED RELEASE | NDA022411 | 88c45123-f475-4dd0-bbac-c261868924ef |
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|
| 1 | NDA022411_001 | discontinued | TRAZODONE HYDROCHLORIDE (150MG) | ORAL | TABLET, EXTENDED RELEASE | False | 2010-02-02 | OLEPTRO |
| 2 | NDA022411_002 | discontinued | TRAZODONE HYDROCHLORIDE (300MG) | ORAL | TABLET, EXTENDED RELEASE | False | 2010-02-02 | OLEPTRO |
| # | id | title | category | type | labeler | last update | version | product(s) |
|---|
| 1 | 88c45123-f475-4dd0-bbac-c261868924ef (view SPL) | These highlights do not include all the information needed to use Oleptro safely and effectively. See full prescribing information for Oleptro.OLEPTRO (trazodone hydrochloride) extended-release tabletsInitial U.S. Approval: 1981 | prescription | Human Prescription | Angelini Pharma Inc. | 2014-06-09 | 10 | 435950080, 435950081 |