Drugs@FDA: FDA-Approved Drugs
Company: TEVA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/11/1987 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/09/2022 | SUPPL-69 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/09/2022 | SUPPL-59 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 07/18/2014 | SUPPL-51 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 07/11/2014 | SUPPL-50 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/01/2014 | SUPPL-49 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/08/2009 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 08/13/2008 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 06/25/2007 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 11/29/2005 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 07/08/2005 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 11/12/2002 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 03/30/2001 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/25/2000 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-12 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/22/1999 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/22/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/04/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/22/1996 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 05/11/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/30/1992 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 12/16/1991 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 09/20/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
TRAZODONE HYDROCHLORIDE
TABLET;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 206923 | ACCORD HLTHCARE |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 071196 | APOTEX INC |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 204852 | AUROBINDO PHARMA |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 072193 | OXFORD PHARMS |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 073137 | SUN PHARM INDUSTRIES |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 071524 | TEVA PHARMS USA |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 202180 | TORRENT |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 205253 | ZYDUS PHARMS |