Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073137
Company: SUN PHARM INDUSTRIES
Company: SUN PHARM INDUSTRIES
| 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 |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | AB | No | No |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 150MG | 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 |
|---|---|---|---|---|---|---|---|
| 03/24/1993 | 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 |
|---|---|---|---|---|---|
| 06/07/2021 | SUPPL-42 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/07/2021 | SUPPL-41 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 07/17/2014 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/25/2014 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/30/2013 | SUPPL-32 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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| 11/13/2007 | SUPPL-28 | Labeling |
Label is not available on this site. |
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| 11/13/2007 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 06/25/2007 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 08/26/2005 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 05/05/2005 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 05/07/2003 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 02/14/2002 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/13/2001 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 05/16/2000 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 04/27/1998 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/27/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/27/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/05/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/04/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/22/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/12/1994 | 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 |
TABLET;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 206923 | ACCORD HLTHCARE |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 071258 | APOTEX |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 204852 | AUROBINDO PHARMA |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 072192 | OXFORD PHARMS |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 073137 | SUN PHARM INDUSTRIES |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 071523 | TEVA PHARMS USA |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 202180 | TORRENT |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 50MG | 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 | 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 |