Drugs@FDA: FDA-Approved Drugs
Company: APOTEX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 50MG | 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 |
---|---|---|---|---|---|
03/22/2023 | SUPPL-49 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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04/20/2020 | SUPPL-47 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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04/20/2020 | SUPPL-45 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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09/11/2014 | SUPPL-41 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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11/19/2013 | SUPPL-40 | 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 | |
08/11/2008 | SUPPL-35 | Labeling |
Label is not available on this site. |
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06/25/2007 | SUPPL-31 | Labeling |
Label is not available on this site. |
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07/08/2005 | SUPPL-29 | Labeling |
Label is not available on this site. |
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04/08/2005 | SUPPL-28 | Labeling |
Label is not available on this site. |
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01/21/2003 | SUPPL-24 | Labeling |
Label is not available on this site. |
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09/13/2000 | SUPPL-22 | Labeling |
Label is not available on this site. |
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12/21/1999 | SUPPL-21 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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07/07/2000 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/20/1999 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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03/11/1999 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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12/01/1998 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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09/25/1998 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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05/06/1997 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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09/18/1996 | SUPPL-14 | Labeling |
Label is not available on this site. |
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12/23/1994 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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10/11/1994 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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04/03/1992 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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04/03/1992 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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09/23/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
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08/06/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
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10/26/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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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 |
---|---|---|---|---|---|
11/19/2013 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/071258Orig1s040, 071196Orig1s063lbl.pdf |
TRAZODONE HYDROCHLORIDE
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 | 211116 | CROSSMEDIKA SA |
TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 218988 | GRANULES |
TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 217740 | GRAVITI PHARMS |
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 |