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General MedicationsORALGeneric

OLEPTRO

TRAZODONE HYDROCHLORIDE

Standard Dose
150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Max Dose
Refer to approved labeling
Primary Use
Review priority: 901 REQUIRED Marketing status: Discontinued
Summary

Approval overview OLEPTRO is listed in Drugs@FDA under application 022411 (NDA).

Review priority: 901 REQUIRED Marketing status: Discontinued Active ingredient TRAZODONE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor ANGELINI PHARMA Submission history Latest submission status date: 2014-07-17 00:00:00.

Structured Monograph

Clinical summary

Approval overview OLEPTRO is listed in Drugs@FDA under application 022411 (NDA). Review priority: 901 REQUIRED Marketing status: Discontinued Active ingredient TRAZODONE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor ANGELINI PHARMA Submission history Latest submission status date: 2014-07-17 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: 901 REQUIRED

Interaction Notes

  • No interaction notes stored yet.
OLEPTRO (TRAZODONE HYDROCHLORIDE) | Drug Monograph | MedicHelpline