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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018207
Company: PRAGMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DESYREL TRAZODONE HYDROCHLORIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
DESYREL TRAZODONE HYDROCHLORIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
DESYREL TRAZODONE HYDROCHLORIDE 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
DESYREL TRAZODONE HYDROCHLORIDE 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No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
12/24/1981 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/18/2018 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018207s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018207Orig1s033ltr.pdf
06/30/2017 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018207s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018207Orig1s032ltr.pdf
07/17/2014 SUPPL-31 Labeling-Patient Package Insert Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018207Orig1s031ltr.pdf
01/12/2005 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18207s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18207s030ltr.pdf
03/17/2004 SUPPL-29 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18207slr029ltr.pdf
06/21/1996 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.
06/25/1996 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.
06/25/1996 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.
02/07/1996 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.
04/14/2000 SUPPL-23 Labeling

Label is not available on this site.
03/05/1990 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.
10/26/1988 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.
04/14/1988 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.
01/22/1988 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.
09/03/1986 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.
11/07/1988 SUPPL-14 Efficacy-New Dosing Regimen

Label is not available on this site.
04/14/2000 SUPPL-13 Labeling

Label is not available on this site.
09/02/1986 SUPPL-12 Efficacy-New Dosing Regimen

Label is not available on this site.
02/26/1986 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.
09/19/1985 SUPPL-10 Labeling

Label is not available on this site.
07/10/1985 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.
09/27/1985 SUPPL-7 Labeling

Label is not available on this site.
10/24/1983 SUPPL-6 Labeling

Label is not available on this site.
11/29/1983 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.
03/25/1985 SUPPL-4 Manufacturing (CMC)-Formulation

Label is not available on this site.
09/03/1986 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.
04/04/1983 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
02/01/1982 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
10/18/2018 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018207s033lbl.pdf
06/30/2017 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018207s032lbl.pdf
01/12/2005 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18207s030lbl.pdf
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