Drugs@FDA: FDA-Approved Drugs
Company: OXFORD PHARMS
| 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 |
|---|---|---|---|---|---|---|---|
| 02/02/1989 | 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 |
|---|---|---|---|---|---|
| 05/19/2020 | SUPPL-56 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/19/2020 | SUPPL-53 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/05/2015 | SUPPL-48 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/12/2015 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 10/29/2007 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 06/26/2007 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 08/15/2005 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 01/05/2005 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 12/26/2002 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 02/19/2002 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/13/2001 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/04/2001 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 12/02/1999 | SUPPL-25 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/02/1999 | SUPPL-24 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/26/2000 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 05/26/2000 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/1999 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/1999 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/18/1998 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/09/1997 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1997 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/11/1996 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/16/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/30/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/05/1993 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/04/1992 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 04/06/1992 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/13/1991 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 04/06/1992 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/25/1991 | SUPPL-2 | 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 |