Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071196
Company: APOTEX INC
Company: APOTEX INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | AB | No | Yes |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | AB | No | No |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 300MG | 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 |
|---|---|---|---|---|---|---|---|
| 03/25/1987 | 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 |
|---|---|---|---|---|---|
| 02/09/2026 | SUPPL-83 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/24/2025 | SUPPL-82 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/22/2023 | SUPPL-76 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 04/20/2020 | SUPPL-73 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/20/2020 | SUPPL-70 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
||
| 09/11/2014 | SUPPL-64 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/19/2013 | SUPPL-63 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/071258Orig1s040, 071196Orig1s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/071258Orig1s040,071196Orig1s063ltr.pdf | |
| 06/02/2015 | SUPPL-62 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/071196s062lbl.pdf | |
| 08/11/2008 | SUPPL-54 | Labeling |
Label is not available on this site. |
||
| 06/25/2007 | SUPPL-50 | Labeling |
Label is not available on this site. |
||
| 12/05/2005 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 09/09/2005 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 04/08/2005 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 01/21/2003 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 09/13/2000 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 10/25/1999 | SUPPL-41 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 12/21/1999 | SUPPL-40 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/26/1999 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/25/1999 | SUPPL-37 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/26/1999 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/25/1998 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/1999 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/1999 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 04/26/1999 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 04/26/1999 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/1999 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/1999 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/1999 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/1999 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/1999 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/1999 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/06/1997 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/18/1996 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 12/23/1994 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/11/1994 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/23/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 08/06/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 09/20/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/02/2015 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/071196s062lbl.pdf | |
| 11/19/2013 | SUPPL-63 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/071258Orig1s040, 071196Orig1s063lbl.pdf |
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 | 211116 | CROSSMEDIKA SA |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 218988 | GRANULES |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 217740 | GRAVITI PHARMS |
| 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 |
TABLET;ORAL; 150MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 206923 | ACCORD HLTHCARE |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 071196 | APOTEX INC |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 204852 | AUROBINDO PHARMA |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 211116 | CROSSMEDIKA SA |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 218988 | GRANULES |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 217740 | GRAVITI PHARMS |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 071525 | PLIVA |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 073137 | SUN PHARM INDUSTRIES |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 202180 | TORRENT |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 150MG | TABLET;ORAL | Prescription | No | AB | 205253 | ZYDUS PHARMS |
TABLET;ORAL; 300MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 300MG | TABLET;ORAL | Prescription | No | AB | 206923 | ACCORD HLTHCARE |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 300MG | TABLET;ORAL | Prescription | No | AB | 071196 | APOTEX INC |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 300MG | TABLET;ORAL | Prescription | No | AB | 204852 | AUROBINDO PHARMA |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 300MG | TABLET;ORAL | Prescription | No | AB | 211116 | CROSSMEDIKA SA |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 300MG | TABLET;ORAL | Prescription | No | AB | 218988 | GRANULES |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 300MG | TABLET;ORAL | Prescription | No | AB | 217740 | GRAVITI PHARMS |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 300MG | TABLET;ORAL | Prescription | No | AB | 202180 | TORRENT |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 300MG | TABLET;ORAL | Prescription | No | AB | 205253 | ZYDUS PHARMS |